Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: Rocuronium; Drug: Sugammadex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298831

P05943 (Other Identifier)

MK-8616-023 (Other Identifier)

19.4.311 (Other Identifier)

Details and patient eligibility

About

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Enrollment: 224 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

Exclusion criteria

• Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
• Participants taking medications known to interfere with neuromuscular blocking agents.
• Participants who are of child-bearing potential, pregnant, and breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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224 participants in 1 patient group

Sugammadex

Experimental group

Description:

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.

Treatment:

Drug: Rocuronium

Drug: Sugammadex