NCT04027751

The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,508 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Emergence Delirium
• Postoperative Delirium

Interventions

Type	Name	Description
DRUG	Tropisetron	Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
DRUG	Placebos	Investigators administrated intravenously 0.9% saline solution as a placebo

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-12-31
• Completion: 2022-03-31
• First posted: 2019-07-22
• Last updated: 2020-03-11

Locations

1 site across 1 country: China