Trial Outcomes & Findings for UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study (NCT NCT03284307)
NCT ID: NCT03284307
Last Updated: 2023-04-13
Results Overview
The difference in spontaneous EEG slow wave activity over posterior cortex between states of consciousness measured with high-density EEG equipment and reported in spectral power in the delta band (1-4 Hz) at electrode Oz. Disconnected conscious experience (dreaming), connected conscious experience (awareness of the external world), and unconsciousness (no report) was assessed when participants were roused from sedation or sleep.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
Intraoperative (During sedation-- up to 8 hours)
Results posted on
2023-04-13
Participant Flow
Participants were recruited via an email that was sent to UW-Madison students and staff from August 2017 through March 2020. Interested participants would discuss study commitment and preliminary screening criteria with the study team over the phone. Eligible participants would meet with a faculty anesthesiologist at a screening visit to complete informed consent and for a history and physical examination and basic neuropsychological assessment to determine subsequent study visit eligibility.
Participants were assigned to a drug if they were both eligible and reconsented the morning of the visit. Drug visits occurred in a sequence: Dexmedetomidine, Ketamine, Propofol, and then Midazolam. The same participant could participate in all drug visits if they were eligible, and a minimum of 28 days had past since their previous drug visit. All participants interested in a drug visit were asked to also complete a sleep visit which occurred before the first drug visit if possible.
Participant milestones
| Measure |
All Study Participants
Participants completed sedation visits in the order of dexmedetomidine, ketamine, propofol, and midazolam. There was a washout period of at least 28 days between sedation visits. Subjects were also asked to complete a separate overnight sleep visit with an EEG. Participants reconsented at each sleep and sedation visit. If a patient was inappropriate for one sedative, due to a specific contraindication to that drug (and not the study in general) but were eligible for another drug, then they progressed through the order of sedatives while skipping that inappropriate drug.
At each drug visit, participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Completed Sedation and/or Sleep Visit
|
27
|
|
Overall Study
Completed Sedation Visit
|
21
|
|
Overall Study
Sleep
|
15
|
|
Overall Study
Dexmedetomidine
|
20
|
|
Overall Study
Ketamine
|
15
|
|
Overall Study
Propofol
|
6
|
|
Overall Study
Midazolam
|
0
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed for each row is the number of participants who completed that visit.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=27 Participants
Participants completed sedation visits in the order of dexmedetomidine, ketamine, propofol, and midazolam. There was a washout period of at least 28 days between sedation visits. Subjects were also asked to complete a separate overnight sleep visit with an EEG. Participants reconsented at each sleep and sedation visit. If a patient was inappropriate for one sedative, due to a specific contraindication to that drug (and not the study in general) but were eligible for another drug, then they progressed through the order of sedatives while skipping that inappropriate drug.
At each drug visit, participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
|
|---|---|
|
Age, Continuous
Total
|
23.44 years
STANDARD_DEVIATION 4.60 • n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Age, Continuous
Sleep
|
25.13 years
STANDARD_DEVIATION 5.33 • n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Age, Continuous
Dexmedetomidine
|
22.95 years
STANDARD_DEVIATION 3.75 • n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Age, Continuous
Ketamine
|
21.47 years
STANDARD_DEVIATION 3.14 • n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Age, Continuous
Propofol
|
22.83 years
STANDARD_DEVIATION 4.17 • n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Total · Female
|
7 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Total · Male
|
20 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Sleep · Female
|
4 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Sleep · Male
|
11 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Dexmedetomidine · Female
|
6 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Dexmedetomidine · Male
|
14 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Ketamine · Female
|
5 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Ketamine · Male
|
10 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Propofol · Female
|
2 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Sex: Female, Male
Propofol · Male
|
4 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Total · Hispanic or Latino
|
2 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Total · Not Hispanic or Latino
|
17 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Total · Unknown or Not Reported
|
8 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Sleep · Hispanic or Latino
|
1 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Sleep · Not Hispanic or Latino
|
6 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Sleep · Unknown or Not Reported
|
8 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Dexmedetomidine · Hispanic or Latino
|
1 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Dexmedetomidine · Not Hispanic or Latino
|
11 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Dexmedetomidine · Unknown or Not Reported
|
8 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Ketamine · Hispanic or Latino
|
1 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Ketamine · Not Hispanic or Latino
|
7 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Ketamine · Unknown or Not Reported
|
7 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Propofol · Hispanic or Latino
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Propofol · Not Hispanic or Latino
|
2 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Ethnicity (NIH/OMB)
Propofol · Unknown or Not Reported
|
4 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · American Indian or Alaska Native
|
0 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · Asian
|
1 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · Black or African American
|
2 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · White
|
15 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · More than one race
|
0 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Total · Unknown or Not Reported
|
8 Participants
n=27 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · American Indian or Alaska Native
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · Asian
|
1 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · Black or African American
|
1 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · White
|
4 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · More than one race
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Sleep · Unknown or Not Reported
|
8 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · American Indian or Alaska Native
|
0 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · Asian
|
1 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · Black or African American
|
1 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · White
|
10 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · More than one race
|
0 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Dexmedetomidine · Unknown or Not Reported
|
8 Participants
n=20 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · American Indian or Alaska Native
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · Asian
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · Black or African American
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · White
|
8 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · More than one race
|
0 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Ketamine · Unknown or Not Reported
|
7 Participants
n=15 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · American Indian or Alaska Native
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · Asian
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · Black or African American
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · White
|
2 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · More than one race
|
0 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Race (NIH/OMB)
Propofol · Unknown or Not Reported
|
4 Participants
n=6 Participants • Number analyzed for each row is the number of participants who completed that visit.
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Intraoperative (During sedation-- up to 8 hours)Population: No midazolam visit was ever conducted because no interested participants had reached that step of the drug sequence after it was added to the protocol in November of 2019.This was in large part due to the shutdown of in-person research activities in March of 2020 from the COVID-19 pandemic.
The difference in spontaneous EEG slow wave activity over posterior cortex between states of consciousness measured with high-density EEG equipment and reported in spectral power in the delta band (1-4 Hz) at electrode Oz. Disconnected conscious experience (dreaming), connected conscious experience (awareness of the external world), and unconsciousness (no report) was assessed when participants were roused from sedation or sleep.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=15 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=6 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
n=15 Participants
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Occipital Delta Power Spectral Density by Conscious State and Study Group.
Connected Consciousness
|
2.37 log10(μV^2)
Interval 2.31 to 2.46
|
1.62 log10(μV^2)
Interval 1.57 to 1.68
|
2.05 log10(μV^2)
Interval 1.94 to 2.15
|
—
|
2.1 log10(μV^2)
Interval 2.03 to 2.18
|
|
Occipital Delta Power Spectral Density by Conscious State and Study Group.
Disconnected Consciousness
|
2.57 log10(μV^2)
Interval 2.53 to 2.61
|
1.7 log10(μV^2)
Interval 1.57 to 1.84
|
2.34 log10(μV^2)
Interval 2.22 to 2.5
|
—
|
2.58 log10(μV^2)
Interval 2.52 to 2.65
|
|
Occipital Delta Power Spectral Density by Conscious State and Study Group.
Unconsciousness
|
2.68 log10(μV^2)
Interval 2.61 to 2.75
|
1.46 log10(μV^2)
Interval 1.16 to 1.83
|
2.51 log10(μV^2)
Interval 2.31 to 2.68
|
—
|
2.63 log10(μV^2)
Interval 2.47 to 2.83
|
SECONDARY outcome
Timeframe: Intraoperative (During sedation-- up to 8 hours)Population: There was no data collected for Midazolam or Sleep for this outcome measure.
The number of instances of disconnected conscious experience (dreaming) versus connected conscious experience (awareness of the external world) during sedation is measured by subject self-report at the time of researcher initiated inquiry.
Outcome measures
| Measure |
Dexmedetomidine
n=20 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=15 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=6 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Number of Instances of Disconnected Conscious Experience (Dreaming) vs Connected Conscious Experience (Awareness of External World).
Instances of Connected Consciousness
|
70 number of instances
|
180 number of instances
|
56 number of instances
|
—
|
—
|
|
Number of Instances of Disconnected Conscious Experience (Dreaming) vs Connected Conscious Experience (Awareness of External World).
Instances of Disconnected Consciousness
|
226 number of instances
|
30 number of instances
|
22 number of instances
|
—
|
—
|
SECONDARY outcome
Timeframe: Intraoperative (During sedation-- up to 8 hours)Population: No data was collected for this outcome measure for Midazolam or Sleep
The ability to identify shapes/images in visual illusions measured by the NIH Toolbox. Will be reported by a computed score from NIH Toolbox for the Dimensional Change Card Sort Test (DCCS) and the Flanker Inhibitory Control \& Attention Test (Flanker). Both Flanker and DCCS use a 2-vector scoring method that takes accuracy and reaction time (if accuracy \>=80%) into account, resulting in a computed score that can range in value from 0-10. A higher score indicates better performance on the test.
Outcome measures
| Measure |
Dexmedetomidine
n=4 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=7 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=2 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
Baseline NIH Toolbox Card Sorting Score
|
8.83 score on a scale
Standard Deviation 1.21
|
9.29 score on a scale
Standard Deviation 0.59
|
9.45 score on a scale
Standard Deviation 0.95
|
—
|
—
|
|
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
Sedation NIH Toolbox Card Sorting Score
|
7.85 score on a scale
Standard Deviation 1.49
|
8.2 score on a scale
Standard Deviation 0.99
|
6.94 score on a scale
Standard Deviation 4.16
|
—
|
—
|
|
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
Baseline NIH Toolbox Flanker Score
|
9.14 score on a scale
Standard Deviation 0.67
|
8.99 score on a scale
Standard Deviation 0.83
|
9.48 score on a scale
Standard Deviation 0.12
|
—
|
—
|
|
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
Sedation NIH Toolbox Flanker Score
|
6.62 score on a scale
Standard Deviation 0.88
|
8.47 score on a scale
Standard Deviation 0.93
|
8.36 score on a scale
Standard Deviation 0.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Intraoperative (During sedation-- up to 8 hours)Population: No data was collected for this outcome measure for Midazolam or Sleep
The ability to match sounds and images measured by the predictive coding task. Will be reported by a proportion correct as a decimal.
Outcome measures
| Measure |
Dexmedetomidine
n=18 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=15 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=5 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Effect of Study Drug on Ability to Correctly Identify Images
Baseline Predictive Coding Task Accuracy
|
0.916 proportion correct
Standard Deviation 0.07
|
0.899 proportion correct
Standard Deviation 0.07
|
0.91 proportion correct
Standard Deviation 0.09
|
—
|
—
|
|
Effect of Study Drug on Ability to Correctly Identify Images
Sedation Predictive Coding Task Accuracy
|
0.793 proportion correct
Standard Deviation 0.09
|
0.763 proportion correct
Standard Deviation 0.1
|
0.734 proportion correct
Standard Deviation 0.15
|
—
|
—
|
SECONDARY outcome
Timeframe: Intraoperative (During sedation-- up to 8 hours)Population: There was no data collected for this outcome measure for Midazolam or Sleep.
Subjects will have a list of words read to them while under sedation and their ability to hear these words and form implicit memories of them will be assessed using a two-alternative forced choice task. Results will be reported as the average number of correct responses out of sixteen.
Outcome measures
| Measure |
Dexmedetomidine
n=18 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=12 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=5 Participants
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Effect of Study Drug on Ability to Form Implicit Memory
|
8 correct responses
Standard Deviation 2.47
|
8.17 correct responses
Standard Deviation 1.70
|
9 correct responses
Standard Deviation 1.58
|
—
|
—
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ketamine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Propofol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine
n=20 participants at risk
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Dexmedetomidine-specific activities: Rapid infusion of 3.0 mg kg-1 h-1 was administered over a 10 min period followed by a 0.5 mg kg-1 h-1 maintenance infusion to achieve the first drug step. The second drug step was similarly achieved by a 10 min infusion of 3.0 mg kg-1 h-1 followed by a 1.5 mg kg-1 h-1 maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Ketamine
n=15 participants at risk
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Ketamine-specific activities: Ketamine was titrated using up to a 4.5mg/kg bolus over 10 minutes followed by 0.1-0.5mg/min intravenous infusion with 5 minutes between increments and titrated to desired observed alertness/sedation level. This infusion rate may be slowed further or stopped for patient safety concerns. Infusion rates will be adjusted using information from the target-controlled infusion model clinical judgment. Short-lived emergence delirium (confusion on awakening) may occur on emergence from ketamine anesthesia and this will be managed through standard clinical practice including administration of midazolam (up to 4mg IV) if required. Duration of drug exposure was limited to 4 hours.
|
Propofol
n=6 participants at risk
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Propofol-specific activities: A target-controlled infusion model used to predict plasma concentrations of propofol at 0.5 mcg/mL increments allowing 5-minutes to equilibrate between any step change. Dosing will be confined to FDA approved limits with up to a 2.5mg/kg bolus over 1 to 3 minute followed by an infusion of 50-200mcg/kg/min titrated to the desired observed alertness/sedation levels. Drug exposure was limited to 4 hours.
|
Midazolam
Standard drug visit activities: Participants were fitted with a saline gel EEG cap and a pre-sedation recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. Once the pre-sedation recording was collected, the faculty anesthesiologist began administering the study drug. A new EEG recording was started to monitor brain waves while all of the pre-sedation activities were repeated after the administration of the study drug.
Midazolam-specific activities: Initial boluses of up to 0.35mg/kg followed by doses up to 0.1mg/kg/h as a maintenance infusion. Duration of drug exposure was limited to 4 hours.
|
Sleep
n=15 participants at risk
Participants were fitted with a saline gel EEG cap and a pre-sleep recording was collected. Participants' brain waves were recorded during rest, while responding to a standardized wake report form, and while performing a predictive coding cognitive task on a computer. After the pre-sleep recording, participants laid down within 30 minutes of their usual bedtime and were left to sleep for 2-3 hours. After this period, the participant was woken up every 15-30 minutes to answer standardized wake report form questions. After awaking a final time, the participant repeated 10 minutes of awake eyes open and eyes closed recordings as well as the predictive coding cognitive task on a computer.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Cardiac disorders
Bradycardia
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
13.3%
2/15 • Number of events 2 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
26.7%
4/15 • Number of events 4 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Cardiac disorders
Mild Chest Pain
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Injury, poisoning and procedural complications
Pain at injection site
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/6 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/20 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
6.7%
1/15 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
16.7%
1/6 • Number of events 1 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
—
0/0 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
0.00%
0/15 • 24 hours after drug or sleep visit.
Every participant was called by the study team the day after a drug or sleep visit and asked to report any adverse events experienced since the visit. If any reported, study team reported them to study physician, and completed a serious adverse event tracking log if needed. If the adverse event fulfilled criteria outlined in protocol, it would be reported to the internal review board at UW- Madison.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place