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)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-28

Study Completion Date

2007-01-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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rocuronium+sugammadex

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.

Group Type EXPERIMENTAL

sugammadex

Intervention Type DRUG

Administered as an intravenous (IV) infusion

rocuronium

Intervention Type DRUG

Administered as an IV infusion

rocuronium+neostigmine

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.

Group Type ACTIVE_COMPARATOR

neostigmine

Intervention Type DRUG

Administered as an IV infusion

rocuronium

Intervention Type DRUG

Administered as an IV infusion

glycopyrrolate

Intervention Type DRUG

Administered as an IV infusion

vecuronium+sugammadex

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.

Group Type EXPERIMENTAL

sugammadex

Intervention Type DRUG

Administered as an intravenous (IV) infusion

vecuronium

Intervention Type DRUG

Administered as an IV infusion

vecuronium+neostigmine

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 70.0 μg/kg neostigmine (up to a maximum dose of 5 mg) was administered in combination with 14.0 μg/kg glycopyrrolate.

Group Type ACTIVE_COMPARATOR

neostigmine

Intervention Type DRUG

Administered as an IV infusion

vecuronium

Intervention Type DRUG

Administered as an IV infusion

glycopyrrolate

Intervention Type DRUG

Administered as an IV infusion

Interventions

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sugammadex

Administered as an intravenous (IV) infusion

Intervention Type DRUG

neostigmine

Administered as an IV infusion

Intervention Type DRUG

vecuronium

Administered as an IV infusion

Intervention Type DRUG

rocuronium

Administered as an IV infusion

Intervention Type DRUG

glycopyrrolate

Administered as an IV infusion

Intervention Type DRUG

Other Intervention Names

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Org 25969 MK-8616 BRIDION® PROSTIGMIN® NORCURON® ZEMURON® ROBINUL®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No