The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1508 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-03-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Emergence Delirium Postoperative Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tropisetron

Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.

Group Type EXPERIMENTAL

Tropisetron

Intervention Type DRUG

Investigators administrated intravenously Tropisetron 5mg before anesthesia induction

Placebo

Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Investigators administrated intravenously 0.9% saline solution as a placebo

Interventions

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Tropisetron

Investigators administrated intravenously Tropisetron 5mg before anesthesia induction

Intervention Type DRUG

Placebos

Investigators administrated intravenously 0.9% saline solution as a placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No