A Bridging Trial Comparing Org 25969 at Reappearance of T2 in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.208B)(P05971)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00552617
First received: October 31, 2007
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

The objective of the trial was to establish the dose-response relation of Org 25969 given as a reversal agent of rocuronium or vecuronium at reappearance of T2 during sevoflurane anesthesia for Caucasian subjects.


Condition Intervention Phase
Anesthesia, General
Drug: sugammadex (Org 25969)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7 and 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
rocuronium and placebo
Drug: Placebo

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of Placebo IV was administered

Experimental: 2
rocuronium and 0.5 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 3
rocuronium and 1.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 4
rocuronium and 2.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 5
rocuronium and 4.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Placebo Comparator: 6
vecuronium and placebo
Drug: Placebo

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of Placebo IV was administered

Experimental: 7
vecuronium and 0.5 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 8
vecuronium and 1.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 9
vecuronium and 2.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969
Experimental: 10
vecuronium and 4.0 mg/kg Org 25969
Drug: sugammadex (Org 25969)

After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arms 2-5) or 0.1 mg/kg vecuronium (arms 7-10).

Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.

At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered

Other Name: Org 25969

Detailed Description:

For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Org 25969 has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial 19.4.208B was conducted in Europe and set up to establish the doseresponse relationship of Org 25969 given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian subjects. In addition to recovery time, also pharmacokinetics and safety of Org 25969 were to be evaluated.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of ASA class 1 - 3;
  • Subjects at least 20 years but under 65 years of age;
  • Caucasian subjects;
  • Subjects scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia with an anticipated duration of about 1.5-3 hours;
  • Subjects who had 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 NMB and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic 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 expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
  • Female subjects who were pregnant;
  • Female subjects of childbearing potential not using birth control or using only oral contraception as birth control;
  • Subjects who were breast-feeding;
  • Subjects who had already participated in CT 19.4.208B, or in another trial with Org 25969;
  • Subjects who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.208B.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00552617     History of Changes
Other Study ID Numbers: 19.4.208B
Study First Received: October 31, 2007
Last Updated: October 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Vecuronium Bromide
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014