Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Anesthesia, General

Treatments

Drug: rocuronium

Drug: neostigmine

Drug: glycopyrrolate

Drug: sugammadex

Drug: vecuronium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00473694

P05945 (Other Identifier)

19.4.302 (Other Identifier)

MK-8616-025 (Other Identifier)

Details and patient eligibility

About

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

American Society of Anesthesiologists (ASA) Class 1 to 4
18 years or older
Scheduled to undergo an elective surgical procedure under general anesthesia requiring the use of rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular block
Scheduled for surgery in supine position
Given written informed consent

Exclusion criteria

Participants in whom a difficult intubation is expected due to anatomical malformations
Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
Known or suspected to have a (family) history of malignant hyperthermia
Known or suspected to have an allergy to narcotics, muscle relaxants, or other medications used during surgery
Receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics, and magnesium (Mg2+)
Participants in whom the use of neostigmine and/or glycopyrrolate may be contraindicated
Female participants who are pregnant or breast-feeding
Females participants of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence]
Participants who had already participated in an Org 25969 trial
Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

182 participants in 4 patient groups

rocuronium+sugammadex

Experimental group

Description:

Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 post-tetanic counts (PTC) and after the last dose of rocuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.

Treatment:

Drug: sugammadex

Drug: rocuronium

rocuronium+neostigmine

Active Comparator group

Description:

Participants received a single bolus dose of 0.60 mg/kg rocuronium prior to intubation. The neuromuscular block was maintained with 0.15 mg/kg rocuronium if needed. At 1-2 PTC and after the last dose of rocuronium, a single bolus dose of 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.

Treatment:

Drug: glycopyrrolate

Drug: neostigmine

Drug: rocuronium

vecuronium+sugammadex

Experimental group

Description:

Participants received a single bolus dose of 0.1 mg/kg vecuronium prior to intubation. The neuromuscular block was maintained with 0.015 mg/kg vecuronium if needed. At 1-2 PTC and after the last dose of vecuronium, a single bolus dose of 4.0 mg/kg sugammadex was administered.

Treatment:

Drug: vecuronium

Drug: sugammadex

vecuronium+neostigmine

Active Comparator group

Description:

Treatment:

Drug: vecuronium

Drug: glycopyrrolate

Drug: neostigmine