The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

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

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).

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

Conditions
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Emergence Delirium, Postoperative Delirium

Intervention / Treatment
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* Drug: Tropisetron
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written consent given Scheduled to undergo elective non-cardiac surgeries under general anesthesia ASA Physical Score I-III Exclusion Criteria: Patients with a history of neurological disease, such as Alzheimer disease. Patients with a history of psychiatric disease Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment. the Montreal Cognitive Assessment (MoCA) scores below 10 Patients who have severe intraoperative adverse events, such as cardiac arrest. Patients with contraindication of tropisetron.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of emergence delirium | 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: 15min after excubation 30min after excubation 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 |
| --- | --- | --- |
| Incidence of postoperative delirium | 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 |  | Within 3 days after surgery | 
| Postoperative Pain | 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 | 
| Length of Hospital stay |  | From the date of admission until discharged from hospital, up to 30 days | 
| Adverse events | Other adverse events within 3 days after surgery were noted | Within 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tropisetron, emergence delirium, postoperative delirium