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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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