RecruitingPhase 2NCT05574400

The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study


Sponsor

University of Michigan

Enrollment

250 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.


Eligibility

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a dose of caffeine given before surgery can reduce the risk of postoperative delirium — a state of confusion and disorientation that commonly occurs in older patients after surgery. Delirium after surgery can lead to longer hospital stays and worse long-term outcomes. **You may be eligible if...** - You are 70 years or older - You are having non-cardiac, non-brain surgery under general anesthesia - You are expected to stay in the hospital for at least 48 hours after surgery - You are willing and able to follow study procedures **You may NOT be eligible if...** - Your surgery is an emergency - You have a history of seizures - You have a caffeine intolerance or allergy - You weigh more than 130 kg - You have severe cognitive impairment that would prevent consent - You are enrolled in another conflicting study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDextrose Water

Dextrose 5% in water

DRUGCaffeine citrate

Low-dose caffeine citrate (1.5 mg/kg)

DRUGCaffeine citrate

High-dose Caffeine citrate (3 mg/kg)


Locations(1)

Michigan Medicine

Ann Arbor, Michigan, United States

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NCT05574400


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