Trial Outcomes & Findings for A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia (NCT NCT03360903)
NCT ID: NCT03360903
Last Updated: 2019-11-18
Results Overview
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.
COMPLETED
PHASE4
8 participants
15 minutes
2019-11-18
Participant Flow
Participant milestones
| Measure |
Placebo Then Caffeine
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).
Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
* Saline
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
* Caffeine citrate
|
Caffeine Then Placebo
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).
Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
* Saline
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
* Caffeine citrate
|
|---|---|---|
|
First Intervention
STARTED
|
4
|
4
|
|
First Intervention
COMPLETED
|
4
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
4
|
4
|
|
Washout (2 Weeks)
COMPLETED
|
4
|
4
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
4
|
|
Second Intervention
COMPLETED
|
4
|
4
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Baseline characteristics by cohort
| Measure |
Placebo Then Caffeine
n=4 Participants
Anesthetized volunteers will be allowed to wake after injection of saline (placebo control) followed by a washout period and then anesthetized again and allowed to wake after injection of caffeine (15 mg/ kg).
Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
* Saline
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
* Caffeine citrate
|
Caffeine Then Placebo
n=4 Participants
Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg) followed by a washout period and then anesthetized again and allowed to wake after injection of saline (placebo control).
Placebo: Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
Other Names:
* Saline
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
Other Names:
* Caffeine citrate
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
27.0 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 minutesPopulation: Due to technical problems during the study, data was not collected and analyzed.
The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject will be asked to complete a series of psychomotor tests, if they are able. Otherwise the testing started at 30 minutes. The tests will be repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of "feel good" or "feel bad" displayed on a computer screen. Test subjects will be asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test will be repeated every 15 minutes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test will be applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants are asked to memorize a string of numbers. Afterwards, a computer will flash a series of random numbers on the screen and the participant is asked whether the number on the computer screen are part of the earlier string or not. In three rounds, participants are given a string of 2, then 4, then 6 numbers. The latency until the subject answers the question is also monitored.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test is first applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants are asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flash on the screen. The computer program tracks the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appears.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
A bispectral index (BIS) measurement system is employed to measure depth of anesthesia. In particular, we wish to determine whether BIS exhibits more rapid recovery after caffeine compared to control.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes after terminating anesthesia.Population: Due to technical problems during the study, data was not collected and analyzed.
This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Caffeine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place