Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101 AM1) (DANCHEONG)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT01050543

First received: January 14, 2010

Last updated: April 10, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 14, 2010
Last Updated Date	April 10, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 10, 2012)	Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 [ Time Frame: From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes) ] [ Designated as safety issue: No ] Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds & assessing twitch response at the adductor pollicis muscle. T1 & T4 refer to the magnitudes (height) of the 1st & 4th twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated complete recovery.
Original Primary Outcome Measures ^ICMJE (submitted: January 14, 2010)	Time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine. [ Time Frame: Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of administration to recovery of the T4/T1 ratio of 0.9. ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01050543 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE (submitted: January 14, 2010)	Time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio of 0.9 is below 3 minutes. [ Time Frame: Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of administration to recovery of the T4/T1 ratio of 0.9. ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101 AM1)
Official Title ^ICMJE	A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade
Brief Summary	This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Neuromuscular Blockade
Intervention ^ICMJE	Drug: sugammadex sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion Other Name: SCH 900616; Bridion Drug: neostigmine neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion Other Name: neostigmine methylsulfate
Study Arm (s)	Experimental: Sugammadex Intervention: Drug: sugammadex Active Comparator: Neostigmine Intervention: Drug: neostigmine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	128
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: American Society of Anesthesiologists Class 1 or 2 or 3 >=18 years of age and of either sex scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address Exclusion Criteria: expected difficult intubation due to anatomic malformations expected transfer to intensive care unit after surgery neuromuscular disorders affecting neuromuscular blockade significant hepatic or renal dysfunction require use of pneumatic tourniquet during surgery (family) history of malignant hyperthermia allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01050543
Other Study ID Numbers ^ICMJE	P06101
Has Data Monitoring Committee	No
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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