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

Phase 4UnknownNCT04195204

Beijing Chao Yang Hospital72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Postoperative Cognitive Dysfunction Postoperative Delirium

Interventions

TropisetronDRUG

Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.

PlacebosDRUG

Investigators administrated intravenously saline solution as a placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

The feasibility of tropisetron intervention on POCD in patients after cardiac surgery

The feasibility will mainly be determined by the percentage of participants who completed the whole study procedure from recruitment to the 1-month follow-up.

Time frame: Within 30 days after surgery

Secondary Outcomes

Incidence of postoperative cognitive dysfunction

Screening of the patients regarding a POCD by Repeatable Battery Neuropsychological Status (RBANS). Besides, the changes in SCWT and IRI scores will be an additional indication of POCD.

Time frame: One day before surgery, discharge from hospital and 1 month after surgery

Incidence of postoperative delirium

Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)

Time frame: Within 7 days after surgery

Functional status measurement

Screening of the patients by Barthel Index scale ranging from 0 to 100, where less than 20 indicates total dependence, 20-35 scores indicate severe dependence, 40-55 scores indicate moderate dependence, equal or over 60 indicates mild dependency and 100 indicates independence.

Time frame: One day before surgery and 1 month after surgery

EEG frequency spectrum

Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB: 1. before anesthesia introduction 2. during anesthesia 3. 1 day after surgery 4. 2 days after surgery 5. 3 days after surgery

Time frame: Within 3 days after surgery

Postoperative Pain

Data from ClinicalTrials.gov

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