Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 22, 2017

Primary Completion Date

May 15, 2018

Study Completion Date

May 24, 2018

Conditions
General Anaesthesia
Interventions
DRUG

Remimazolam

Lyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol)

DRUG

Propofol

Emulsion for infusion, 10 mg/mL in 20-mL glass vials

DRUG

Fentanyl

Solution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)

DRUG

Rocuronium bromide

Solution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)

Trial Locations (6)

Unknown

FSBI Central Clinical Hospital and Polyclinic of Adminisatration of the President of the Russian Federation, Moscow

FSBI Russian National Medical and Surgical Center n.a. N.I.Pirogov, Moscow

SBHI City Clinical Hospital №1 n.a. N.I. Pirogov, Moscow

SBHI City Clinical Hospital №64 n.a. V.V. Vinogradov, Moscow

SBHI Institute of Surgery n.a. A.V.Vishevsky, Moscow

SBHI Moscow Clinical Research and Practical center of Department of Healthcare of the city of Moscow, Moscow

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Synergy Research Inc.

INDUSTRY

lead

R-Pharm

INDUSTRY