← Back to Search

Methylxanthine

Caffeine for Postoperative Delirium

Phase 2
Recruiting
Led By Phillip Vlisides, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (>/= 70 years old) undergoing non-cardiac, non-intracranial neurologic, non-major vascular surgery requiring general anesthesia with a planned admission for at least 48 hours.
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative baseline through postoperative day three afternoon
Awards & highlights

Study Summary

This trial tests if caffeine can reduce the risk of post-op delirium after major surgery.

Who is the study for?
This trial is for adults aged 70 or older who are having major surgery (not involving the heart, brain, or major blood vessels) that requires general anesthesia and a hospital stay of at least two days. Participants must be able to follow study procedures and give informed consent. People with acute liver failure, weight over 130 kg, pheochromocytoma diagnosis, caffeine allergy/intolerance, severe kidney issues pre-surgery, significant hearing/vision loss, non-English speakers or those in emergency/outpatient surgeries cannot join.Check my eligibility
What is being tested?
The CAPACHINOS-2 Study is testing whether caffeine can help reduce problems with thinking and confusion (delirium) after surgery. Patients will receive either caffeine citrate or dextrose water to see if there's a difference in their recovery from cognitive impairments following their operations.See study design
What are the potential side effects?
Caffeine may cause side effects like restlessness, nervousness, excitement, insomnia; gastrointestinal complaints; muscle twitching; rambling flow of thought and speech; tachycardia or cardiac arrhythmia; periods of inexhaustibility; psychomotor agitation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 70 or older and will have surgery under general anesthesia with a planned hospital stay of at least 48 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of surgery through postoperative day three afternoon
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of surgery through postoperative day three afternoon for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delirium
Secondary outcome measures
Agitation
Cumulative Opioid Consumption
Delirium Duration
+4 more
Other outcome measures
30-Day Cognitive Function
30-Day Physical Function
Anesthetic Emergence
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-dose CaffeineExperimental Treatment1 Intervention
Prepared intravenous low-dose caffeine citrate (1.5 mg/kg) at multiple postoperative time points over a 30-minute infusion period.
Group II: High-dose CaffeineExperimental Treatment1 Intervention
Prepared intravenous high-dose caffeine citrate (3 mg/kg) at multiple postoperative time points over a 30-minute infusion period.
Group III: ControlPlacebo Group1 Intervention
Prepared intravenous piggyback solution of 5 percent dextrose water at multiple postoperative time points over a 30-minute infusion period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caffeine citrate
2008
Completed Phase 4
~300

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,813 Total Patients Enrolled
35 Trials studying Delirium
38,379 Patients Enrolled for Delirium
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,732 Total Patients Enrolled
4 Trials studying Delirium
3,867 Patients Enrolled for Delirium
Phillip Vlisides, MDPrincipal InvestigatorAssistant Professor of Anesthesiology
1 Previous Clinical Trials
71 Total Patients Enrolled

Media Library

Caffeine citrate (Methylxanthine) Clinical Trial Eligibility Overview. Trial Name: NCT05574400 — Phase 2
Delirium Research Study Groups: High-dose Caffeine, Control, Low-dose Caffeine
Delirium Clinical Trial 2023: Caffeine citrate Highlights & Side Effects. Trial Name: NCT05574400 — Phase 2
Caffeine citrate (Methylxanthine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574400 — Phase 2
Delirium Patient Testimony for trial: Trial Name: NCT05574400 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the researchers actively seeking participants for this experiment?

"Clinicaltrials.gov confirms that this specific medical research project is not currently recruiting participants, as the last update was made on October 6th 2022 and it was initially posted on January 1st 2023. However, there are 704 other trials with urgent recruitment needs at present."

Answered by AI

What safety implications arise from consuming low amounts of caffeine?

"Our expert team at Power gave low-dose caffeine a score of 2, as it has been proven to be safe but not yet effective in clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Illinois
Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Michigan Medicine

Why did patients apply to this trial?

I thought It would be appropriate for me.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
Phillip Vlisides 2023. "The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05574400.
~158 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top