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

Mild Cognitive Impairment Postoperative Delirium Postoperative Cognitive Dysfunction

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

Inclusion Criteria3

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.

Exclusion Criteria13

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