Clinical trial NCT04195204: A Pilot Trial Evaluating the Effect of Tropisetron on Postoperative Cognitive Dysfunction After Cardiac Surgery
Official title: A Randomized, Double-blind, Placebo-controlled Pilot Trial Evaluating the Effect of Tropisetron on Prevention of Postoperative Cognitive Dysfunction in Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Incidence of postoperative cognitive dysfunction
timeFrame: One day before surgery, discharge from hospital and 1 month after surgery
measure: Incidence of postoperative delirium
timeFrame: Within 7 days after surgery
measure: Functional status measurement
timeFrame: One day before surgery and 1 month after surgery
measure: EEG frequency spectrum
timeFrame: Within 3 days after surgery
measure: Postoperative Pain
timeFrame: Within 7 days after surgery
measure: Sleep Quality
timeFrame: Within 30 days after surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: Within 7 days after surgery
measure: Length of ICU stay
timeFrame: From the date of admission until discharged from ICU, up to 30 days
measure: Length of Hospital stay
timeFrame: From the date of admission until discharged from hospital, up to 30 days
measure: Incidence of major adverse cardiac and cerebral events
timeFrame: Within 30 days after surgery
measure: Inflammatory biomarkers
timeFrame: Within 7 days after surgery
Other outcomes:
measure: Incidence of major adverse cardiac and cerebral events
timeFrame: Within 30 days after surgery
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
Study officials:
References: