Caffeine may clear Post-Surgery brain fog in seniors

NCT ID NCT05574400

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests whether giving caffeine to adults aged 70 and older after major surgery can lower their risk of postoperative delirium—a state of sudden confusion. Researchers will compare low-dose and high-dose caffeine against a placebo in 250 participants. The goal is to see if a common, safe substance can improve mental recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: caffeine citrate
What this could lead to: If it works, this could point toward a simple, low-cost way to prevent confusion and cognitive decline after major surgery in older adults.
What could go wrong: This is a mid-stage trial with only 250 participants, so results may not apply to everyone. Caffeine can cause side effects like jitters or heart issues, and it might not reduce delirium at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

250 people

The number who actually took part.

Started

Feb 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease cognitive disorder Cognitive Dysfunction Emergence Delirium Postoperative Cognitive Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mild cognitive impairment Postoperative cognitive dysfunction Postoperative delirium

Caffeine may clear Post-Surgery brain fog in seniors

What the study statuses mean