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NCT03360903 · ClinicalTrials.gov registry record · Phase 4

A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

A Phase 4 study, sponsored by University of Chicago.

Completed
Registry status
Phase 4
Development phase
8
Enrollment target

NCT03360903: Completed Phase 4 study, sponsored by University of Chicago.

NCT03360903 is a Phase 4 study that has completed, run by University of Chicago. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03360903, a Phase 4 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 4
Development phase
8 participants
Enrollment target

Study 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.

Primary Outcome

The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to "emerge" from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes.

Interventions

  • DRUG Placebo
  • DRUG Caffeine

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-01-02
Est. Completion 2019-06-01
Phase Phase 4
University of Chicago

796 total trials

What the finished NCT03360903 record still lists

NCT03360903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03360903 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03360903 about?

NCT03360903 is a clinical study titled "A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia". 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 caffein...

What is the current status of trial NCT03360903?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2018-01-02. Estimated completion is 2019-06-01.

What interventions are being tested in trial NCT03360903?

The interventions under investigation include: Placebo (DRUG), Caffeine (DRUG).

Who is sponsoring clinical trial NCT03360903?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03360903's enrollment target sits among peer trials

8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03360903, the US trial registry maintained by the National Library of Medicine. NCT03360903 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.