NCT05574400 · Phase 2 · ACTIVE NOT RECRUITING
The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study
This trial is testing whether caffeine given around the time of major surgery can reduce the chances of postoperative delirium — the confusion and mental fog that often follows surgery in older adults. It is a Phase 2 trial, meaning researchers are evaluating whether the approach actually works and is safe, not a proven or approved treatment. The comparison group receives a dextrose water placebo.
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're excluded 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-04-21