A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Chao Yang Hospital
• Treatments: Tropisetron

Criteria

Inclusion Criteria:

1. Written consent given

2. Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia

3. ASA Physical Score I-IV

Exclusion Criteria:

1. Inability to give informed consent.

2. Contraindications to tropisetron.

3. Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.

4. History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).

5. History of antipsychotic drug use.

6. Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10