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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01050543
First received: January 14, 2010
Last updated: August 1, 2014
Last verified: August 2014

January 14, 2010
August 1, 2014
February 2010
August 2010   (final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01050543 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Neuromuscular Blockade
  • 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
  • Experimental: Sugammadex
    Intervention: Drug: sugammadex
  • Active Comparator: Neostigmine
    Intervention: Drug: neostigmine
Woo T, Kim KS, Shim YH, Kim MK, Yoon SM, Lim YJ, Yang HS, Phiri P, Chon JY. Sugammadex versus neostigmine reversal of moderate rocuronium-induced neuromuscular blockade in Korean patients. Korean J Anesthesiol. 2013 Dec;65(6):501-7. doi: 10.4097/kjae.2013.65.6.501. Epub 2013 Dec 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01050543
P06101
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP