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

Capital Medical University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Treatments: Drug: Placebos; Drug: Tropisetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04195204

29847819

Details and patient eligibility

About

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.

Full description

Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.

Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function.

We have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. Several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and EEG recordings will be involved in the trial. Moreover, we have assumed a few long-term follow-ups.

Given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Tropisetron

Experimental group

Description:

Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery.

Treatment:

Drug: Tropisetron

Placebo

Placebo Comparator group

Description:

Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery.

Treatment:

Drug: Placebos