CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Caffeine 15 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03360903
NCT03360903Phase 4Completed

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

University of Chicago·interventional·Posted Dec 4, 2017·Updated Nov 18, 2019

In Brief

A Phase 4 clinical trial evaluating Placebo and Caffeine for Anesthesia. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 4, 2017
Enrollment StartJan 2, 2018
Primary CompletionDec 31, 2018
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.6 years ago

Interventions

Placebodrug

Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). Other Names: * Saline

Caffeinedrug

Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). Other Names: * Caffeine citrate