Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451217

19.4.301 (Other Identifier)

P05960

MK-8616-033 (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is of American Society of Anesthesiologists (ASA) 1 - 4;
• Is above or equal to the age of 18;
• Scheduled for surgical procedures with a general anesthesia with the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block;
• Scheduled for surgical procedure in supine position;
• Given written informed consent.

Exclusion criteria

• Participants in whom a difficult intubation because of anatomical malformations was expected;
• Is known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction;
• Is known or suspected to have a (family) history of malignant hyperthermia;
• Is known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
• Is receiving medication in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
• Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
• Had already participated in a sugammadex trial;
• Had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into P05960.
• Females who are pregnant:
• Females of childbearing potential not using any method of birth control: condom or using only hormonal contraception as birth control;
• Females who were breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 4 patient groups

Rocuronium + Sugammadex

Experimental group

Description:

After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered

Treatment:

Drug: Sugammadex

Rocuronium + Neostigmine

Active Comparator group

Description:

After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered

Treatment:

Drug: Neostigmine

Vecuronium + Sugammadex

Experimental group

Description:

After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered

Treatment:

Drug: Sugammadex

Vecuronium + Neostigmine

Active Comparator group

Description:

After the last dose of vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered

Treatment:

Drug: Neostigmine