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

Phase 3

Completed

• Conditions: Anesthesia, Intravenous
• Interventions: Drug: Remimazolam; Drug: Propofol

• Registration Number: NCT03661489
• Lead Sponsor: Paion UK Ltd.

Brief 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

Study Timeline

• Study Start: 2018-07-24
• Study First Submitted: 2018-09-03
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-07
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 469

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Remimazolam 50 mg	Remimazolam	For induction of general anesthesia, remimazolam is co-administered with remifentanil for analgesia and with a muscle relaxant as necessary. For maintenance of general anesthesia remimazolam is titrated to effect. Administration of boluses of remimazolam is allowed. Remifentanil is continued and/or titrated. Boluses of muscle relaxants are given throughout the surgical procedure as needed.
Intravenous Propofol 2%	Propofol	For induction of general anesthesia, propofol is co-administered with remifentanil for analgesia and with a muscle relaxant as necessary. For maintenance of general anesthesia propofol is titrated to effect. Administration of boluses of propofol is allowed. Remifentanil is continued and/or titrated. Boluses of muscle relaxants are given throughout the surgical procedure as needed.

Primary Outcome Measures

Name	Time	Method
Percentage (%) of time of Narcotrend Index (NCI) values ≤ 60 during maintenance phase of general anesthesia (defined as time between the first skin incision and the completion of the last skin suture)	maintenance phase of general anesthesia (time between the first skin incision and the completion of the last skin suture)	The primary efficacy endpoint (PEP) is the anesthetic effect of remimazolam and propofol assessed as percent (%) of time of NCI ≤60 during the maintenance phase of general anesthesia

Secondary Outcome Measures

Name	Time	Method
Number of events of critical decrease(s) in mean arterial blood pressure (MAP)	From start of Investigational Medicinal Product (IMP) administration until 15 minutes after first skin incision	For this endpoint, each event from the following categories will be counted and summed up per patient: * Incidence of MAP dropping below 65 mmHg for at least 1 minute duration; * Incidence of a MAP decrease of more than 20% below the calculated (mean) baseline MAP value for at least 1 minute duration; * Incidence of a MAP decrease of more than 30% below the calculated (mean) baseline MAP value for at least 1 minute duration; * Number of norepinephrine boluses (0.01 mg) required or, if an infusion is used to maintain MAP equal to or above 65 mmHg, then each time interval of 2 minutes duration of continuous norepinephrine infusion will be counted as one event.

Trial Locations

Locations (1)

University of Erlangen; 🇩🇪 Erlangen, Bavaria, Germany