Phase 4
N=8
A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03360903 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); Caffeine (Drug)
- Age
- Adult · 25+ yrs
- Sex
- Male
- Sponsor
- University of Chicago
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes. |
— | — |
| SECONDARY Cognitive Test1 - Visual Analog Scale |
— | — |
| SECONDARY Cognitive Test2 - Sternberg Test of Memory |
— | — |
| SECONDARY Cognitive Test3 - Divided Attention Task |
— | — |
| SECONDARY Bispectral Index |
— | — |
| SECONDARY Mean Arterial Blood Pressure |
— | — |
| SECONDARY Heart Rate |
— | — |
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
- 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 40.
- Female.
- ASA physical status > 1 (normal healthy subject without systematic diseases or conditions)
- Metabolic Equivalents of Functional Capacity (METs) 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.
Data sourced from ClinicalTrials.gov (NCT03360903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.