NCT06092684

The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Laparoscopy
• Anesthesia, Intravenous

Interventions

Type	Name	Description
DRUG	BT-KTM-I	The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.
DRUG	Ketanest®S	The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Timeline

• Start date: 2023-09-20
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2023-10-23
• Last updated: 2024-07-29

Locations

12 sites across 1 country: China