NCT03661489

Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery

Phase III Confirmatory Efficacy and Safety Trial of Remimazolam (CNS7056) Compared With Propofol for Intravenous Anesthesia During Elective Surgery in ASA Class III/IV Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 469 (actual)
• Sponsor: Paion UK Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase III confirmatory trial evaluating the efficacy and safety of remimazolam (CNS7056) compared to propofol for intravenous anesthesia during elective surgery in ASA Class III/IV patients.

Detailed description

This is a Phase III single-blind, randomized, controlled, non-inferiority multi-center trial in American Society of Anesthesiologists (ASA) Class III/IV patients undergoing elective surgery, comparing remimazolam to propofol for induction and maintenance of intravenous anesthesia. In accordance with general anesthetic standard regimen, remimazolam or propofol, will be administered together with remifentanil as analgesic agent, and with a neuromuscular blocker to facilitate intubation and achieve muscle relaxation

Conditions

• Anesthesia, Intravenous

Interventions

Type	Name	Description
DRUG	Remimazolam	For induction and maintenance of general anesthesia
DRUG	Propofol	For induction and maintenance of general anesthesia

Timeline

• Start date: 2018-07-24
• Primary completion: 2020-04-02
• Completion: 2020-04-02
• First posted: 2018-09-07
• Last updated: 2020-05-28

Locations

1 site across 1 country: Germany