NCT03360903

A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Placebo	Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). Other Names: * Saline
DRUG	Caffeine	Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names: * Caffeine citrate

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-12-31
• Completion: 2019-06-01
• First posted: 2017-12-04
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study