Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01GM116119 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
Not provided
At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats to wake much more rapidly from propofol anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?
The propose investigators carrying out a modest trial with 8 test subjects. Each volunteer will be anesthetized twice. Each volunteer will be anesthetized one time and receive an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer will receive an infusion of a relatively low dose of caffeine. The order of saline versus caffeine will be randomized and the study will be done in a double blind manner. We will determine whether emergence from propofol anesthesia will be significantly accelerated by the caffeine infusion. And whether any adverse events are observed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Caffeine | Experimental | 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). |
|
| Caffeine then Placebo | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). Other Names:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes. | 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. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Test1 - Visual Analog Scale | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names:
|
| FG001 | 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:
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (2 Weeks) |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes. | 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. | Due to technical problems during the study, data was not collected and analyzed. | Posted | 15 minutes |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received a saline infusion | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Fox | University of Chicago | (773) 702-0021 | aaronfox@uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2019 | Oct 25, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Caffeine | Drug | Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names:
|
|
| Up to 120 minutes after terminating anesthesia. |
| Cognitive Test2 - Sternberg Test of Memory | 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. | Up to 120 minutes after terminating anesthesia. |
| Cognitive Test3 - Divided Attention Task | 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. | Up to 120 minutes after terminating anesthesia. |
| Bispectral Index | 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. | Up to 120 minutes after terminating anesthesia. |
| Mean Arterial Blood Pressure | This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner. | Up to 120 minutes after terminating anesthesia. |
| Heart Rate | This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner. | Up to 120 minutes after terminating anesthesia. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 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:
Caffeine: Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Cognitive Test1 - Visual Analog Scale | 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. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| Secondary | Cognitive Test2 - Sternberg Test of Memory | 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. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| Secondary | Cognitive Test3 - Divided Attention Task | 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. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| Secondary | Bispectral Index | 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. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| Secondary | Mean Arterial Blood Pressure | This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| Secondary | Heart Rate | This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner. | Due to technical problems during the study, data was not collected and analyzed. | Posted | Up to 120 minutes after terminating anesthesia. |
|
|
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Caffeine | Participants received a caffiene infusion | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
Not provided
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |