The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

March 9, 2020 updated by: Anshi Wu, Beijing Chao Yang Hospital

The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial

The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline 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. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.

To explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (>26 versus 18-26 versus 10-17).

Study Type

Interventional

Enrollment (Anticipated)

1508

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100020
        • Recruiting
        • Beijing Chaoyang Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written consent given
  2. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
  3. ASA Physical Score I-III

Exclusion Criteria:

  1. Patients with a history of neurological disease, such as Alzheimer disease.
  2. Patients with a history of psychiatric disease
  3. Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.
  4. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
  5. the Montreal Cognitive Assessment (MoCA) scores below 10
  6. Patients who have severe intraoperative adverse events, such as cardiac arrest.
  7. Patients with contraindication of tropisetron.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tropisetron
Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.
Drug: Tropisetron
Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
Placebo Comparator: Placebo
Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.
Drug: Placebos
Investigators administrated intravenously 0.9% saline solution as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of emergence delirium
Time Frame: Until the end of post-anesthesia care unit stay, assessed up to 1 hour

Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time:

  1. 15min after excubation
  2. 30min after excubation
  3. At discharge from post-anesthesia care unit (PACU)
Until the end of post-anesthesia care unit stay, assessed up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital stay
Time Frame: From the date of admission until discharged from hospital, up to 30 days
From the date of admission until discharged from hospital, up to 30 days
Postoperative Pain
Time Frame: Within 3 days after surgery
Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
Within 3 days after surgery
Incidence of postoperative delirium
Time Frame: Within 3 days after surgery
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Within 3 days after surgery
Incidence of postoperative nausea and vomiting
Time Frame: Within 3 days after surgery
Within 3 days after surgery
Adverse events
Time Frame: Within 3 days after surgery
Other adverse events within 3 days after surgery were noted
Within 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04719372

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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