The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04027751

Collaborator

(none)

1,508

Enrollment

Location

Arms

Anticipated Duration (Months)

47.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Emergence Delirium Postoperative Delirium	Drug: Tropisetron Drug: Placebos	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

1508 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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: 15min after excubation 30min after excubation At discharge from post-anesthesia care unit (PACU)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.