Clinical trial NCT03360903: A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study to Determine if Caffeine Citrate Accelerates Emergence From Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2017-12-04
Enrollment: 8
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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 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.


Eligibility 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 not 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.

Primary outcomes:
measure: Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
timeFrame: 15 minutes
Secondary outcomes:
measure: Cognitive Test1 - Visual Analog Scale
timeFrame: Up to 120 minutes after terminating anesthesia.
measure: Cognitive Test2 - Sternberg Test of Memory
timeFrame: Up to 120 minutes after terminating anesthesia.
measure: Cognitive Test3 - Divided Attention Task
timeFrame: Up to 120 minutes after terminating anesthesia.
measure: Bispectral Index
timeFrame: Up to 120 minutes after terminating anesthesia.
measure: Mean Arterial Blood Pressure
timeFrame: Up to 120 minutes after terminating anesthesia.
measure: Heart Rate
timeFrame: Up to 120 minutes after terminating anesthesia.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
References: