Expired Study
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Chicago, Illinois 60637


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

IRB15-0897


NCT ID:

NCT02567968


Secondary ID:

1R01GM116119-01


Study Acronym:


Brief Title:

A Study to Determine if Caffeine Accelerates Emergence From Anesthesia


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Male


Minimum Age:

25 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Chicago


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:Aaron Fox, PhD
Principal Investigator
University of Chicago

Study Dates

Start Date:August 2016
Completion Date:May 1, 2017
Completion Type:Actual
Primary Completion Date:May 1, 2017
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 19, 2018
First Received Date:September 30, 2015
First Results Date:June 19, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Heart Rate
Time Frame:Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-a
Safety Issues:False
Description:This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.
Outcome Type:Secondary Outcome
Measure:Mean Arterial Blood Pressure
Time Frame:Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-a
Safety Issues:False
Description:This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.
Outcome Type:Secondary Outcome
Measure:Minute Ventilation
Time Frame:Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to
Safety Issues:False
Description:The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.
Outcome Type:Secondary Outcome
Measure:Bispectral Index
Time Frame:Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-a
Safety Issues:False
Description: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 anes
Outcome Type:Secondary Outcome
Measure:Cognitive Test3 - Divided Attention Task
Time Frame:Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
Safety Issues:False
Description: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 ane
Outcome Type:Secondary Outcome
Measure:Cognitive Test2 - Sternberg Test of Memory
Time Frame:Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.
Safety Issues:False
Description: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 ane
Outcome Type:Secondary Outcome
Measure:Cognitive Test1 - Visual Analog Scale --- Feel Bad
Time Frame:Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
Safety Issues:False
Description: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 subj
Outcome Type:Secondary Outcome
Measure:Cognitive Test1 - Visual Analog Scale --- Feel Good
Time Frame:Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.
Safety Issues:False
Description: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 subj
Outcome Type:Primary Outcome
Measure:Waking Time - Re-establishment of the Gag Reflex.
Time Frame:followed from the end of anesthesia to gag reflex, up to 2 hours
Safety Issues:False
Description: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 anesthetizin

Study Interventions

Intervention Type:Drug
Name:Caffeine
Description:Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.
Arm Name:Caffeine
Other Name:Caffeine citrate
Intervention Type:Drug
Name:Placebo Control
Description:Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.
Arm Name:Placebo
Other Name:Saline

Study Arms

Study Arm Type:Active Comparator
Arm Name:Caffeine
Description:Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Anesthetized volunteers will be allowed to wake after injection of either saline (placebo control) or caffeine (15 mg/ kg). The time to wake will be measured.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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