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5-HT3 Receptor Antagonist

Tropisetron for Postoperative Cognitive Dysfunction

Phase 4
Waitlist Available
Research Sponsored by Beijing Chao Yang Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day before surgery and 1 month after surgery
Awards & highlights

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.

Eligible Conditions
  • Postoperative Cognitive Dysfunction
  • Delirium

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day before surgery, discharge from hospital and 1 month after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day before surgery, discharge from hospital and 1 month after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
Secondary study objectives
EEG frequency spectrum
Functional status measurement
Incidence of postoperative cognitive dysfunction
+4 more
Other study objectives
Incidence of major adverse cardiac and cerebral events

Side effects data

From 2011 Phase 3 trial • 179 Patients • NCT00435370
9%
Other Adverse Event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tropisetron
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TropisetronExperimental Treatment1 Intervention
Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery.
Group II: PlaceboPlacebo Group1 Intervention
Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tropisetron
2016
Completed Phase 3
~27390

Find a Location

Who is running the clinical trial?

Beijing Chao Yang HospitalLead Sponsor
212 Previous Clinical Trials
10,790,712 Total Patients Enrolled
~15 spots leftby Oct 2025
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