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A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02567968
Enrollment
8
Registered
2015-10-05
Start date
2016-08-31
Completion date
2017-05-01
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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 and mice to wake much more rapidly from 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 investigators carried out a modest trial with 8 test subjects. Each volunteer was anesthetized twice. Each volunteer was anesthetized one time and received an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer received an infusion of a relatively low dose of caffeine. The order of saline versus caffeine was randomized and the study was done in a double blind manner. We observed that emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse events were observed.

Interventions

DRUGCaffeine

Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.

DRUGPlacebo Control

Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
25 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 25-40. 2. Male. 3. Normal healthy subject without systematic diseases or conditions. 4. Metabolic Equivalents of Functional Capacity \>= 5. 5. Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA 6. No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases. 7. BMI \< 30 kg/m2. 8. No history of prior difficulty with anesthesia. 9. No personal or family history of malignant hyperthermia. 10. No history of any mental illness. 11. No history of drugs or alcohol abuse (urine drug screens required). 12. Subjects capable of giving consent. 13. Living less than 30 miles away from University of Chicago. 14. No history of seizure disorders. 15. No history of head trauma.

Exclusion criteria

1. Age \<25 or \>40. 2. Female. 3. ASA physical status \> 1 (normal healthy subject without systematic diseases or conditions) 4. Metabolic Equivalents of Functional Capacity (METs) \< 5. 5. High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA 6. History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases 7. BMI\>30 kg/m2. 8. Prior difficulty with anesthesia. 9. Personal or family history of malignant hyperthermia. 10. History of any mental illness. 11. History of drugs or alcohol abuse (urine drug screens required) 12. Subjects capable of giving consent 13. Living more than 30 miles away from University of Chicago. 14. History of seizure disorders. 15. History of head trauma.

Design outcomes

Primary

MeasureTime frameDescription
Waking Time - Re-establishment of the Gag Reflex.followed from the end of anesthesia to gag reflex, up to 2 hoursThe goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a gag response in all test subjects. This objective and unequivocal measurement constituted the emergence time for each subject. The emergence time was defined as the time between terminating the anesthesia and the test subject starting to gag.

Secondary

MeasureTime frameDescription
Cognitive Test1 - Visual Analog Scale --- Feel BadTest was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.
Cognitive Test2 - Sternberg Test of MemoryTest was given at 15, 30, 45, 60 minutes after terminating anesthesia.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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants were asked to memorize a string of numbers. Afterwards, a computer would flash a series of random numbers on the screen and the participant was asked whether the number on the computer screen was part of the earlier string or not. In three rounds, participants were given a string of 2, then 4, then 6 numbers. The latency until the subject answered the question was monitored and this is the data summarized here.
Cognitive Test3 - Divided Attention TaskTest was given at 15, 30, 45, 60 minutes after terminating anesthesia.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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants were asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flashed on the screen. The computer program tracked 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 appeared.
Cognitive Test1 - Visual Analog Scale --- Feel GoodTest was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.
Minute VentilationContinuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.
Mean Arterial Blood PressureContinuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.
Heart RateContinuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.
Bispectral IndexContinuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.A bispectral index (BIS) measurement system was employed to measure depth of anesthesia. Using electrodes attached to the forehead to measure EEG, BIS outputs a dimensionless number between 0 and 100 that is proportional to the brain concentration of anesthetic and is thereby proportional to an individual's level of consciousness (Greenwald S, Chiang HH, Devlin P, Smith C, Sigl J, Chamoun N: The Bispectral Index (Bis2.0) as a Hypnosis Measure. Anesthesiology 1994; 81: A477-a477). When the test subjects arrive, prior to anesthesia, their BIS values are in the range of 95 - 99. That corresponds to an awake and alert state. During anesthesia, most subjects are in the range of 20 - 40, corresponding to an anesthetized state. As the anesthetic wears off, the BIS values rise until they are back in the 95 - 99 range that they were prior to anesthesia. In particular, we wished to determine whether BIS exhibited more rapid recovery after caffeine infusion as compared to saline (control).

Countries

United States

Participant flow

Participants by arm

ArmCount
All Study Participants
Participants who were randomized to either receive Caffeine then Placebo or Placebo then Caffeine
8
Total8

Baseline characteristics

CharacteristicAll Study Participants
Age, Continuous31 years
STANDARD_DEVIATION 4.3
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Black
3 Participants
Race/Ethnicity, Customized
White
3 Participants
Region of Enrollment
United States
8 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 8
other
Total, other adverse events
0 / 80 / 8
serious
Total, serious adverse events
0 / 80 / 8

Outcome results

Primary

Waking Time - Re-establishment of the Gag Reflex.

The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a gag response in all test subjects. This objective and unequivocal measurement constituted the emergence time for each subject. The emergence time was defined as the time between terminating the anesthesia and the test subject starting to gag.

Time frame: followed from the end of anesthesia to gag reflex, up to 2 hours

ArmMeasureValue (MEAN)Dispersion
PlaceboWaking Time - Re-establishment of the Gag Reflex.16.45 minutesStandard Deviation 3.9
CaffeineWaking Time - Re-establishment of the Gag Reflex.9.57 minutesStandard Deviation 5.1
p-value: 0.002paired t-test
Secondary

Bispectral Index

A bispectral index (BIS) measurement system was employed to measure depth of anesthesia. Using electrodes attached to the forehead to measure EEG, BIS outputs a dimensionless number between 0 and 100 that is proportional to the brain concentration of anesthetic and is thereby proportional to an individual's level of consciousness (Greenwald S, Chiang HH, Devlin P, Smith C, Sigl J, Chamoun N: The Bispectral Index (Bis2.0) as a Hypnosis Measure. Anesthesiology 1994; 81: A477-a477). When the test subjects arrive, prior to anesthesia, their BIS values are in the range of 95 - 99. That corresponds to an awake and alert state. During anesthesia, most subjects are in the range of 20 - 40, corresponding to an anesthetized state. As the anesthetic wears off, the BIS values rise until they are back in the 95 - 99 range that they were prior to anesthesia. In particular, we wished to determine whether BIS exhibited more rapid recovery after caffeine infusion as compared to saline (control).

Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.

Population: One subject was missing data at the last timepoint for the Placebo session

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBispectral Index2 min post-anesthesia41.4 units on a scaleStandard Deviation 5.6
PlaceboBispectral Index10 minutes post-anesthesia62.5 units on a scaleStandard Deviation 8
PlaceboBispectral Index6 minutes post-anesthesia55.0 units on a scaleStandard Deviation 10.6
PlaceboBispectral Index12 minutes post-anesthesia62.9 units on a scaleStandard Deviation 11.5
PlaceboBispectral Index4 min post-anesthesia48.5 units on a scaleStandard Deviation 11.9
PlaceboBispectral Index14 minutes post-anesthesia62.6 units on a scaleStandard Deviation 10.7
PlaceboBispectral Index8 minutes post-anesthesia60.3 units on a scaleStandard Deviation 7.9
PlaceboBispectral Index16 minutes post-anesthesia69.1 units on a scaleStandard Deviation 14.2
PlaceboBispectral Index0 minutes post-anesthesia34.1 units on a scaleStandard Deviation 3.8
CaffeineBispectral Index16 minutes post-anesthesia84.1 units on a scaleStandard Deviation 11.9
CaffeineBispectral Index0 minutes post-anesthesia36.3 units on a scaleStandard Deviation 3.5
CaffeineBispectral Index2 min post-anesthesia43.1 units on a scaleStandard Deviation 15.4
CaffeineBispectral Index4 min post-anesthesia55.5 units on a scaleStandard Deviation 13.8
CaffeineBispectral Index6 minutes post-anesthesia58.1 units on a scaleStandard Deviation 11.7
CaffeineBispectral Index8 minutes post-anesthesia69.1 units on a scaleStandard Deviation 11.7
CaffeineBispectral Index10 minutes post-anesthesia71.3 units on a scaleStandard Deviation 9.5
CaffeineBispectral Index12 minutes post-anesthesia76.5 units on a scaleStandard Deviation 12.5
CaffeineBispectral Index14 minutes post-anesthesia82.4 units on a scaleStandard Deviation 11.2
Secondary

Cognitive Test1 - Visual Analog Scale --- Feel Bad

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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.

Time frame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.

Population: Some participants could not be tested at the early timepoints due to not being fully awake etc.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad15 minutes post-anesthesia6.0 units on a scaleStandard Deviation 0
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad30 minutes post-anesthesia17.9 units on a scaleStandard Deviation 20.9
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad45 minutes post-anesthesia13.0 units on a scaleStandard Deviation 14.1
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad60 minutes post-anesthesia9.8 units on a scaleStandard Deviation 10.3
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad75 minutes post-anesthesia6.0 units on a scaleStandard Deviation 8.1
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad90 minutes post-anesthesia7.0 units on a scaleStandard Deviation 7.2
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad105 minutes post-anesthesia6.6 units on a scaleStandard Deviation 11
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Bad120 minutes post-anesthesia4.3 units on a scaleStandard Deviation 4.3
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad120 minutes post-anesthesia4.3 units on a scaleStandard Deviation 6.5
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad15 minutes post-anesthesia27.4 units on a scaleStandard Deviation 24.2
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad75 minutes post-anesthesia8.5 units on a scaleStandard Deviation 12
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad30 minutes post-anesthesia11.6 units on a scaleStandard Deviation 13.3
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad105 minutes post-anesthesia3.9 units on a scaleStandard Deviation 4.3
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad45 minutes post-anesthesia11.8 units on a scaleStandard Deviation 14.7
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad90 minutes post-anesthesia6.4 units on a scaleStandard Deviation 7.4
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Bad60 minutes post-anesthesia10.0 units on a scaleStandard Deviation 12.2
Secondary

Cognitive Test1 - Visual Analog Scale --- Feel Good

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 was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were 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 were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes.

Time frame: Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.

Population: Some participants could not be tested at the early timepoints due to not being fully awake etc.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good15 minutes post-anesthesia29 units on a scaleStandard Deviation 0
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good30 minutes post-anesthesia48.1 units on a scaleStandard Deviation 29.5
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good45 minutes post-anesthesia50.9 units on a scaleStandard Deviation 29
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good60 minutes post-anesthesia62.8 units on a scaleStandard Deviation 26.5
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good75 minutes post-anesthesia60.0 units on a scaleStandard Deviation 28.2
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good90 minutes post-anesthesia61.5 units on a scaleStandard Deviation 26.7
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good105 minutes post-anesthesia66.3 units on a scaleStandard Deviation 24.1
PlaceboCognitive Test1 - Visual Analog Scale --- Feel Good120 minutes post-anesthesia66.0 units on a scaleStandard Deviation 25.1
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good120 minutes post-anesthesia66.8 units on a scaleStandard Deviation 27.7
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good15 minutes post-anesthesia54.8 units on a scaleStandard Deviation 22.4
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good75 minutes post-anesthesia59.3 units on a scaleStandard Deviation 25.9
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good30 minutes post-anesthesia50.3 units on a scaleStandard Deviation 25.4
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good105 minutes post-anesthesia61.9 units on a scaleStandard Deviation 24.3
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good45 minutes post-anesthesia58.1 units on a scaleStandard Deviation 26.5
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good90 minutes post-anesthesia59.5 units on a scaleStandard Deviation 25.7
CaffeineCognitive Test1 - Visual Analog Scale --- Feel Good60 minutes post-anesthesia55.1 units on a scaleStandard Deviation 27.5
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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants were asked to memorize a string of numbers. Afterwards, a computer would flash a series of random numbers on the screen and the participant was asked whether the number on the computer screen was part of the earlier string or not. In three rounds, participants were given a string of 2, then 4, then 6 numbers. The latency until the subject answered the question was monitored and this is the data summarized here.

Time frame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.

Population: Some participants could not be tested at the early timepoints due to not being fully awake etc.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Test2 - Sternberg Test of Memory15 minutes post-anesthesia847 msStandard Deviation 0
PlaceboCognitive Test2 - Sternberg Test of Memory30 minutes post-anesthesia908.9 msStandard Deviation 146.9
PlaceboCognitive Test2 - Sternberg Test of Memory45 minutes post-anesthesia791.1 msStandard Deviation 99.6
PlaceboCognitive Test2 - Sternberg Test of Memory60 minutes post-anesthesia734.4 msStandard Deviation 100.1
CaffeineCognitive Test2 - Sternberg Test of Memory60 minutes post-anesthesia733.5 msStandard Deviation 84.1
CaffeineCognitive Test2 - Sternberg Test of Memory15 minutes post-anesthesia1001.4 msStandard Deviation 182.8
CaffeineCognitive Test2 - Sternberg Test of Memory45 minutes post-anesthesia780.8 msStandard Deviation 127.7
CaffeineCognitive Test2 - Sternberg Test of Memory30 minutes post-anesthesia853.7 msStandard Deviation 176
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 was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants were asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flashed on the screen. The computer program tracked 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 appeared.

Time frame: Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.

Population: Some participants could not be tested at the early timepoints due to not being fully awake etc.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboCognitive Test3 - Divided Attention Task15 minutes post-anesthesia26.3 mm away from optimalStandard Deviation 0
PlaceboCognitive Test3 - Divided Attention Task30 minutes post-anesthesia38.2 mm away from optimalStandard Deviation 19.9
PlaceboCognitive Test3 - Divided Attention Task45 minutes post-anesthesia35.2 mm away from optimalStandard Deviation 25.3
PlaceboCognitive Test3 - Divided Attention Task60 minutes post-anesthesia24.5 mm away from optimalStandard Deviation 9.5
CaffeineCognitive Test3 - Divided Attention Task60 minutes post-anesthesia23.4 mm away from optimalStandard Deviation 6.4
CaffeineCognitive Test3 - Divided Attention Task15 minutes post-anesthesia38.2 mm away from optimalStandard Deviation 4.3
CaffeineCognitive Test3 - Divided Attention Task45 minutes post-anesthesia29.1 mm away from optimalStandard Deviation 13.3
CaffeineCognitive Test3 - Divided Attention Task30 minutes post-anesthesia29.8 mm away from optimalStandard Deviation 14
Secondary

Heart Rate

This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.

Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboHeart RatePre-anesthesia79 beats per minuteStandard Deviation 13
PlaceboHeart Rate5 minutes after anesthesia71 beats per minuteStandard Deviation 16
PlaceboHeart Rate30 minutes after anesthesia79 beats per minuteStandard Deviation 7
PlaceboHeart Rate60 minutes after anesthesia67 beats per minuteStandard Deviation 6
CaffeineHeart Rate60 minutes after anesthesia67 beats per minuteStandard Deviation 9
CaffeineHeart RatePre-anesthesia75 beats per minuteStandard Deviation 11
CaffeineHeart Rate30 minutes after anesthesia75 beats per minuteStandard Deviation 9
CaffeineHeart Rate5 minutes after anesthesia66 beats per minuteStandard Deviation 10
Secondary

Mean Arterial Blood Pressure

This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.

Time frame: Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMean Arterial Blood PressurePre-anesthesia89 mmHgStandard Deviation 9
PlaceboMean Arterial Blood Pressure5 minutes after anesthesia72 mmHgStandard Deviation 9
PlaceboMean Arterial Blood Pressure30 minutes after anesthesia94 mmHgStandard Deviation 10
PlaceboMean Arterial Blood Pressure60 minutes after anesthesia96 mmHgStandard Deviation 6
CaffeineMean Arterial Blood Pressure60 minutes after anesthesia98 mmHgStandard Deviation 6
CaffeineMean Arterial Blood PressurePre-anesthesia90 mmHgStandard Deviation 7
CaffeineMean Arterial Blood Pressure30 minutes after anesthesia98 mmHgStandard Deviation 8
CaffeineMean Arterial Blood Pressure5 minutes after anesthesia79 mmHgStandard Deviation 15
Secondary

Minute Ventilation

The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.

Time frame: Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboMinute VentilationPost-infusion6.2 L/minuteStandard Deviation 1.4
PlaceboMinute VentilationEmergence7.5 L/minuteStandard Deviation 2.1
CaffeineMinute VentilationPost-infusion7.2 L/minuteStandard Deviation 1.1
CaffeineMinute VentilationEmergence8.5 L/minuteStandard Deviation 3.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026