Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00825812
First received: January 15, 2009
Last updated: April 29, 2014
Last verified: April 2014

January 15, 2009
April 29, 2014
January 2010
September 2010   (final data collection date for primary outcome measure)
Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9. [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ] [ 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 and assessing twitch response at the adductor pollicis muscle. Nerve stimulation was to continue until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached >= 0.9. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade, with a value of 1.0 representing full recovery.

The primary analysis was the comparison between sugammadex & neostigmine among Chinese subjects; other comparisons were secondary.

Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.9 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00825812 on ClinicalTrials.gov Archive Site
Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8. [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ] [ Designated as safety issue: No ]
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. The greater the T4/T1 ratio the greater the recovery from neuromuscular blockade.
  • Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.7 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
  • Time from start of administration of IMP to recovery of the T4/T1 ratio to 0.8 [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
A Multi-center, Randomized, Parallel-group, Active-controlled, Safety-assessor Blinded Trial, Comparing the Efficacy and Safety of 2.0 mg.Kg-1 Sugammadex With 50 μg.Kg-1 Neostigmine Administered at Reappearance of T2 After Rocuronium in Chinese and European ASA I-III Subjects Undergoing Elective Surgery Under Propofol Anesthesia

The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Anesthesia, General
  • Neuromuscular Blockade
  • Drug: Sugammadex
    After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex was administered.
    Other Name: Org 25969, Bridion®
  • Drug: neostigmine
    After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 50 µg/kg neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
    Other Name: Neostigmine with atropine
  • Experimental: Sugammadex in Caucasian Subjects
    At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
    Intervention: Drug: Sugammadex
  • Active Comparator: Neostigmine in Caucasian Subjects
    At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
    Intervention: Drug: neostigmine
  • Experimental: Sugammadex in Chinese Subjects
    At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
    Intervention: Drug: Sugammadex
  • Active Comparator: Neostigmine in Chinese Subjects
    At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
    Intervention: Drug: neostigmine
Wu X, Oerding H, Liu J, Vanacker B, Yao S, Dahl V, Xiong L, Claudius C, Yue Y, Huang Y, Abels E, Rietbergen H, Woo T. Rocuronium blockade reversal with sugammadex vs. neostigmine: randomized study in Chinese and Caucasian subjects. BMC Anesthesiol. 2014 Jul 12;14:53. doi: 10.1186/1471-2253-14-53. eCollection 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

-Subjects who are willing to provide informed consent; be between 18 and 64 years old; are American Society of Anaesthesiology (ASA) class 1-3 (extremes included); scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires neuromuscular blockade using rocuronium; be compliant with the dose/visit schedules, and use an accepted method of contraception (if applicable).

For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address.

Exclusion Criteria:

-Subjects with expected difficult intubation, neuromuscular disorders affecting neuromuscular blockade, significant renal/hepatic dysfunction, use of a tourniquet, (family) history of malignant hyperthermia, allergy to general anesthesia medications, contraindication to study drugs, breast feeding, pregnant, participation in previous or new trials, a clinically significant condition that may interfere with the trial, or membership in the (family of) study/sponsor staff.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00825812
P05768, 19.4.324
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

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