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)

Phase 3

Completed

• Conditions: Anesthesia, General
• Interventions: Drug: Sugammadex; Drug: Succinylcholine; Drug: Rocuronium

• Registration Number: NCT00474253
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-10
• Primary Completion: 2006-08-22
• Study Completion: 2006-09-09
• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2007-05-15
• Study First Posted: 2007-05-16
• Results First Submitted: 2018-12-18
• Results First Submitted QC: 2018-12-18
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Results First Posted: 2019-03-29
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocuronium + Sugammadex	Sugammadex	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.
Rocuronium + Sugammadex	Rocuronium	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.
Succinylcholine	Succinylcholine	Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration	Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine	Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.

Secondary Outcome Measures

Name	Time	Method
Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration	Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine	Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 refers to the amplitude (height) of the first twitch after TOF nerve stimulation.
Number of Participants Experiencing General Muscle Weakness	Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine	The number of participants experiencing general muscle weakness was assessed by the investigator as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessments were performed every 15 minutes until the absence of general muscle weakness. A standardized examination form was used to determine the presence or absence of muscle weakness in various muscle groups.
Level of Consciousness: Number of Participants Awake and Oriented	Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine	The number of participants who were awake and oriented was assessed as part of an overall assessment of the clinical level of consciousness. The clinical level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.
Level of Consciousness: Number of Participants Arousable With Minimal Stimulation	Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine	The number of participants aroused with minimal stimulation was assessed as part of an overall assessment of level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.
Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation	Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine	The number of participants responsive only to tactile stimulation was assessed as part of an overall assessment of the level of consciousness. The level of consciousness was used as a measure of recovery from neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. Attempts were made to arouse participants every 15 minutes with mild prodding, mild shaking, and asking questions regarding name, location, and day of the week. The assessment ended once the participant was awake and fully orientated.
Number of Participants Able to Perform 5-Second Head Lift	Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine	The number of participants who were able to lift their head for 5 seconds was assessed as a measure of recovery following neuromuscular blockade at two time points: prior to transfer to the recovery room after extubation and prior to discharge from the recovery room. The assessment was performed every 15 minutes until the first successful 5-second head lift was achieved.