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

Completed · Phase 2

Conditions studied: Postoperative Delirium, Postoperative Cognitive Dysfunction, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT05574400

Run by

University of Michigan

People needed

250

Starts

2023-02-20

Expected to finish

2026-05-20

Last updated by the study team

2026-07-16

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Provision of signed and dated informed consent form.

You may not qualify if…

• Emergency surgery
• Outpatient surgery
• Severe cognitive impairment precluding the capacity for informed consent
• Seizure disorder history
• Intolerance or allergy to caffeine (based on subjective reporting or objective documentation)
• Weight >130 kg (as a 3 mg/kg dose would approach the upper limit of daily intake recommended by the FDA)
• Enrollment in conflicting research study
• Patients in acute liver failure
• Acute kidney injury preoperatively
• Diagnosis of pheochromocytoma
• Active carcinoid syndrome
• Severe audiovisual impairment
• Non-English speaking

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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