Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: Succinylcholine; Drug: Rocuronium; Drug: Sugammadex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474253

MK-8616-026 (Other Identifier)

19.4.303 (Other Identifier)

P05946 (Other Identifier)

Details and patient eligibility

About

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Enrollment: 115 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
• 18 to 65 years of age (inclusive);
• Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
• Scheduled for surgery in supine position;
• Body mass index (BMI) < 30;
• Given written informed consent.

Exclusion criteria

• Has ischemic heart disease or history of myocardial infarction within the last year;
• May experience difficult intubation due to anatomical malformations;
• Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
• Known or suspected family history of malignant hyperthermia;
• Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
• Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
• Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
• Females who are pregnant or breast-feeding;
• Females of childbearing potential who are not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
• Has already participated in a sugammadex trial including Protocol 19.4.303.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Rocuronium + Sugammadex

Experimental group

Description:

Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex.

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Succinylcholine

Active Comparator group

Description:

Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

Treatment:

Drug: Succinylcholine