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5-HT3 Receptor Antagonist

Tropisetron for Delirium

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
Pivotal Trial
Drug Has Already Been Approved

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
  • Delirium
  • Postoperative Cognitive Dysfunction

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 major adverse cardiac and cerebral events
+5 more

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
218 Previous Clinical Trials
10,796,116 Total Patients Enrolled
2 Trials studying Delirium
1,608 Patients Enrolled for Delirium
~14 spots leftby Dec 2025
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