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

RECRUITINGPhase 2Sponsored by University of Michigan
Actively Recruiting
PhasePhase 2
SponsorUniversity of Michigan
Started2023-02-20
Est. completion2026-04-30
Eligibility
Age70 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 70 Years+Healthy volunteers accepted
Inclusion Criteria:

1. 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.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Provision of signed and dated informed consent form.

Exclusion Criteria:

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

Conditions4

Alzheimer's DiseaseMild Cognitive ImpairmentPostoperative Cognitive DysfunctionPostoperative Delirium

Locations1 site

Michigan Medicine
Ann Arbor, Michigan, 48109
Phillip Vlisides, MD734-936-4280pvliside@med.umich.edu

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