150
Participants
Start Date
August 22, 2017
Primary Completion Date
May 15, 2018
Study Completion Date
May 24, 2018
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)
Propofol
Emulsion for infusion, 10 mg/mL in 20-mL glass vials
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)
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)
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
Lead Sponsor
Synergy Research Inc.
INDUSTRY
R-Pharm
INDUSTRY