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)

NCT00474253 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: P0594619.4.303MK-8616-026
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration

  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.

  Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine

Secondary Outcomes (6)

• 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

• Level of Consciousness: Number of Participants Awake and Oriented

  Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

• Level of Consciousness: Number of Participants Arousable With Minimal Stimulation

  Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

• Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation

  Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

• Number of Participants Able to Perform 5-Second Head Lift

  Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine

Study Arms (2)

Rocuronium + Sugammadex

EXPERIMENTAL

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.

Drug: Sugammadex; Drug: Rocuronium

Succinylcholine

ACTIVE COMPARATOR

Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

Drug: Succinylcholine

Interventions

Sugammadex DRUG

Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex

Also known as: Org 25969, MK-8616

Rocuronium + Sugammadex

Succinylcholine DRUG

Single bolus IV dose of 1.0 mg/kg succinylcholine

Succinylcholine

Rocuronium DRUG

Single bolus IV dose of 1.2 mg/kg rocuronium

Also known as: Zemuron®

Rocuronium + Sugammadex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.

  PMID: 19387176 DERIVED

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Interventions

Sugammadex; Succinylcholine; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 16, 2007
• Study Start: February 10, 2006
• Primary Completion: August 22, 2006
• Study Completion: September 9, 2006
• Last Updated: April 11, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-03