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The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:
A Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of BT-KTM-I Versus Ketanest® S for General Anesthesia in Elective Laparoscopic Surgery

Clinical Trial Summary

The objective is to evaluate the efficacy and safety of BT-KTM-I(Esketamine Hydrochloride Injection produced by Chengdu Brilliant Pharmaceutical Co., Ltd.) for general anesthesia, using the Originator drug Ketanest®S(Esketamine Hydrochloride Injection) as a positive control.

Clinical Trial Description

This is a multicenter, randomized, double-blind, positive drug parallel controlled clinical trial, planned to include 358 subjects, including 179 in the experimental group and 179 in the control group. The entire study was divided into a screening period, surgery day, and follow-up observation period. The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. The experiment used vital signs, physical examination, laboratory examination, 12-lead electrocardiogram examination, and adverse events/serious adverse events for safety evaluation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06092684
Study type Interventional
Source Chengdu Brilliant Pharmaceutical Co., Ltd.
Contact Wen Ouyang, MD
Phone 0731-88618151
Email Ouyangwen133@vip.sina.com
Status Not yet recruiting
Phase Phase 3
Start date October 2023
Completion date April 2024
View Details
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