NCT06740201

A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery

A Clinical Validation Study to Evaluate the Accuracy of a Target Controlled Infusion Model of Cipepofol in Patients With General Anesthesia During Elective Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center (each center independently conducts the study according to the same research protocol), randomized, and open-label clinical study. The main objective is to verify and optimize the accuracy of the target-controlled infusion model of cipepofol.

Detailed description

Subjects who meet the enrollment criteria will be randomly assigned at a 1:1 ratio to two groups with different plasma target-controlled concentrations (Cp) during the induction period: the low-concentration group (Group L) with a concentration of 0.9 μg/ml and the high-concentration group (Group H) with a concentration of 1.2 μg/ml. An interim analysis will be conducted after approximately 5% of the subject data has been collected in each group, including but not limited to indicators such as the effect-site equilibrium rate constant (Ke0).

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Cipepofol	Adjust plasma target-controlled concentration

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-03-30
• Completion: 2025-05-30
• First posted: 2024-12-18
• Last updated: 2025-01-27

Locations

2 sites across 1 country: China