The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

Phase 4

• Conditions: Postoperative Delirium; Emergence Delirium
• Interventions: Drug: Placebos; Drug: Tropisetron

• Registration Number: NCT04027751
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-22
• Study Start: 2019-08-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1508

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.
Tropisetron	Tropisetron	Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.

Primary Outcome Measures

Name	Time	Method
Incidence of emergence delirium	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	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)
Incidence of postoperative nausea and vomiting	Within 3 days after surgery
Postoperative Pain	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.
Length of Hospital stay	From the date of admission until discharged from hospital, up to 30 days
Adverse events	Within 3 days after surgery	Other adverse events within 3 days after surgery were noted

Trial Locations

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, China