Status:
COMPLETED
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Anesthesia
Eligibility:
MALE
25-40 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- Age 25-40.
- Male.
- Normal healthy subject without systematic diseases or conditions.
- Metabolic Equivalents of Functional Capacity \>= 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
- No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
- BMI \< 30 kg/m2.
- No history of prior difficulty with anesthesia.
- No personal or family history of malignant hyperthermia.
- No history of any mental illness.
- No history of drugs or alcohol abuse (urine drug screens required).
- Subjects capable of giving consent.
- Living less than 30 miles away from University of Chicago.
- No history of seizure disorders.
- No history of head trauma.
Exclusion
- Age \<25 or \>40.
- Female.
- ASA physical status \> 1 (normal healthy subject without systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs) \< 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
- History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
- BMI\>30 kg/m2.
- Prior difficulty with anesthesia.
- Personal or family history of malignant hyperthermia.
- History of any mental illness.
- History of drugs or alcohol abuse (urine drug screens required)
- Subjects not capable of giving consent
- Living more than 30 miles away from University of Chicago.
- History of seizure disorders.
- History of head trauma.
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03360903
Start Date
January 2 2018
End Date
June 1 2019
Last Update
November 18 2019
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637