Trial Outcomes & Findings for Sedline EEG Guided Depth of Anesthesia (NCT NCT05051982)
NCT ID: NCT05051982
Last Updated: 2024-01-16
Results Overview
total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Results posted on
2024-01-16
Participant Flow
Participant milestones
| Measure |
Study Group
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=51 Participants
|
51 Participants
n=51 Participants
|
102 Participants
n=102 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=51 Participants
|
20 Participants
n=51 Participants
|
41 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=51 Participants
|
31 Participants
n=51 Participants
|
61 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
51 participants
n=51 Participants
|
51 participants
n=51 Participants
|
102 participants
n=102 Participants
|
|
Height
|
171 centimeters
STANDARD_DEVIATION 12 • n=51 Participants
|
171 centimeters
STANDARD_DEVIATION 11 • n=51 Participants
|
171 centimeters
STANDARD_DEVIATION 11 • n=102 Participants
|
|
Weight
|
80 kilograms
STANDARD_DEVIATION 20 • n=51 Participants
|
79 kilograms
STANDARD_DEVIATION 20 • n=51 Participants
|
80 kilograms
STANDARD_DEVIATION 20 • n=102 Participants
|
|
BMI
|
27 kilograms / meters^2
STANDARD_DEVIATION 6 • n=51 Participants
|
27 kilograms / meters^2
STANDARD_DEVIATION 6 • n=51 Participants
|
27 kilograms / meters^2
STANDARD_DEVIATION 6 • n=102 Participants
|
|
Baseline Systolic Blood Pressure
|
131 mmHg
STANDARD_DEVIATION 19 • n=51 Participants
|
139 mmHg
STANDARD_DEVIATION 22 • n=51 Participants
|
135 mmHg
STANDARD_DEVIATION 21 • n=102 Participants
|
|
Baseline Diastolic Blood Pressure
|
74 mmHg
STANDARD_DEVIATION 12 • n=51 Participants
|
80 mmHg
STANDARD_DEVIATION 15 • n=51 Participants
|
77 mmHg
STANDARD_DEVIATION 14 • n=102 Participants
|
|
ASA physical status
ASA 2
|
1 Participants
n=51 Participants
|
7 Participants
n=51 Participants
|
8 Participants
n=102 Participants
|
|
ASA physical status
ASA 3
|
49 Participants
n=51 Participants
|
43 Participants
n=51 Participants
|
92 Participants
n=102 Participants
|
|
ASA physical status
ASA 4
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Opioid Naïve or Tolerant
Naïve
|
44 Participants
n=51 Participants
|
35 Participants
n=51 Participants
|
79 Participants
n=102 Participants
|
|
Opioid Naïve or Tolerant
Tolerant
|
7 Participants
n=51 Participants
|
16 Participants
n=51 Participants
|
23 Participants
n=102 Participants
|
|
Type of Surgery
GI/Colorectal
|
33 Participants
n=51 Participants
|
31 Participants
n=51 Participants
|
64 Participants
n=102 Participants
|
|
Type of Surgery
GYN
|
2 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Type of Surgery
Other
|
0 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Type of Surgery
Urologic
|
16 Participants
n=51 Participants
|
18 Participants
n=51 Participants
|
34 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is giventotal average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Average Anesthetic
|
1.1890 percentage of sevoflurane
Standard Deviation 0.2571
|
1.2906 percentage of sevoflurane
Standard Deviation 0.2069
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is giventhe total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone.
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
Midazolam
|
1.29 mg
Standard Deviation 1.46
|
1.49 mg
Standard Deviation 1.46
|
|
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
Ketamine
|
43.98 mg
Standard Deviation 38.54
|
45.40 mg
Standard Deviation 42.95
|
|
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
Hydromorphone
|
0.39 mg
Standard Deviation 0.57
|
0.41 mg
Standard Deviation 0.47
|
|
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
Methadone
|
1.18 mg
Standard Deviation 0.80
|
4.07 mg
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is giventhis will be defined as an episode of mean arterial pressure of \<65 mmHg
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Time Period of Hypotension
|
27.18 minutes (with MAP < 65)
Standard Deviation 31.43
|
27.41 minutes (with MAP < 65)
Standard Deviation 34.52
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is givenPopulation: Please note, the units listed below are the standard units used in clinical practice for these medications
phenylephrine, norepinephrine
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)
Phenylephrine
|
1442.55 mcg
Standard Deviation 1489.29
|
4077.20 mcg
Standard Deviation 2845.07
|
|
Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)
Norepinephrine
|
79.45 mcg
Standard Deviation 70.08
|
374.62 mcg
Standard Deviation 330.02
|
SECONDARY outcome
Timeframe: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hoursFollowing the procedure, images and data from the Sedline device were evaluated to determine what percentage of the case a patient's processed EEG displayed isoelectricity (burst suppression). A burst-suppression (or suppression-burst) pattern is a discontinuous EEG, with periods of marked suppression or isoelectric intervals alternating with "bursts" of activity, with or without embedded epileptiform features (Bauer et al., 2013)
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Occurrence of EEG Isoelctricity
|
13.60 % (of case with burst suppression)
Standard Deviation 24.85
|
21.28 % (of case with burst suppression)
Standard Deviation 32.58
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is givenephedrine
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Dosage of Vasopressor (Ephedrine)
|
17.06 mg
Standard Deviation 18.26
|
13.86 mg
Standard Deviation 22.9
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is givenvasopressin
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Dosage of Vasopressor (Vasopressin)
|
0.84 Units
Standard Deviation 0.59
|
2.63 Units
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is giventhe total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl.
Outcome measures
| Measure |
Study Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.
Sedline EEG in View: EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
|
Control Group
n=51 Participants
Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist.
|
|---|---|---|
|
Total Hypnotic Agents (Fentanyl)
|
139.22 mcg
Standard Deviation 69.33
|
173.04 mcg
Standard Deviation 101.22
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Timothy Webb
Indiana University School of Medicine (Dept of Anesthesia)
Phone: 2196893636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place