Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00379613
First received: September 21, 2006
Last updated: October 2, 2009
Last verified: October 2009

September 21, 2006
October 2, 2009
November 2003
June 2004   (final data collection date for primary outcome measure)
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9. [ Time Frame: After administration of rocuronium ] [ Designated as safety issue: No ]
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9.
Complete list of historical versions of study NCT00379613 on ClinicalTrials.gov Archive Site
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8. [ Time Frame: After administration of rocuronium ] [ Designated as safety issue: No ]
Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7; Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.
Not Provided
Not Provided
 
Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)(COMPLETED)
A Multi-Center Randomized Safety Assessor-Blinded Placebo-Controlled Parallel and Dose Escalating Dose-Finding Trial in Subjects of ASA 1 - 2 to Assess the Safety, Efficacy and PK of Sugammadex Administered at 5 Min. After Administration of 1.2 mg/kg Esmeron

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anesthesia, General
  • Drug: sugammadex

    After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

    At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

    Other Name: Org 25969
  • Drug: Placebo

    After induction of anesthesia an intubation dose of NMBA was administered IV: 1.2 mg/kg rocuronium (arms 2-6)

    At 5 minutes after administration of rocuronium, the randomized single dose of sugammadex 2.0 to 16.0 mg/kg IV was administered

  • Placebo Comparator: 1
    rocuronium + 16.0 mg/kg Org 25969
    Intervention: Drug: Placebo
  • Experimental: 2
    rocuronium + 2.0 mg/kg Org 25969
    Intervention: Drug: sugammadex
  • Experimental: 3
    rocuronium + 4.0 mg/kg Org 25969
    Intervention: Drug: sugammadex
  • Experimental: 4
    rocuronium + 8.0 mg/kg Org 25969
    Intervention: Drug: sugammadex
  • Experimental: 5
    rocuronium + 12.0 mg/kg Org 25969
    Intervention: Drug: sugammadex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
June 2004
June 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA 1 - 2 between the ages of 18 and 64, inclusive
  • Scheduled for surgical procedures with an anticipated duration of anesthesia of at least 90 minutes, without further need for muscle relaxation other than for intubation
  • Scheduled for surgery in supine position
  • Given written informed consent

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations was expected
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction
  • Subjects known or suspected to have a (family) history of malignant hyperthermia
  • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
  • Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants and Mg2+
  • Subjects who had already participated in CT 19.4.205
  • Subjects who had participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.205
  • Female subjects who are pregnant: in females pregnancy was to be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who were not of childbearing potential i.e. at least 2 years postmenopausal or underwent tubal ligation or an hysterectomy
  • Females of childbearing potential not using an acceptable method of birth control: condom or diaphragm with spermicide, vasectomized partner (>6 months), IUD, abstinence
  • Subjects giving breast-feeding
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00379613
19.4.205
Yes
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
October 2009

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