Org 25969 After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (19.4.312)(P05949)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00559468
First received: November 14, 2007
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg.kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in subjects after continuous infusion of rocuronium and before the administration of Org 25969, under either propofol or sevoflurane anesthesia.


Condition Intervention Phase
Anesthesia, General
Drug: Sugammadex
Phase 3

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, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Org 25969, Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Secondary Outcome Measures:
  • Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.8 [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: December 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol maintenance anesthesia
Propofol maintenance anesthesia, continuous infusion of rocuronium and 4.0 mg/kg Org 25969
Drug: Sugammadex
single dose 4.0 mg/kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium
Other Name: Org 25969
Experimental: Sevoflurane maintenance anesthesia
Sevoflurane maintenance anesthesia, continuous infusion of rocuronium and 4.0 mg/kg Org 25969
Drug: Sugammadex
single dose 4.0 mg/kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium
Other Name: Org 25969

  Eligibility

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

Inclusion Criteria:

  • Subjects at least 20 years but under 65 years of age;
  • Subjects of ASA class 1-3;
  • Subjects scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
  • Subjects scheduled for a surgical procedure in supine position;
  • Subjects who had given written informed consent.

Exclusion Criteria:

  • Subjects in whom difficult intubation was expected because of anatomical malformations;
  • Subjects known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
  • Subjects known or suspected to have a (family) history of malignant hyperthermia;
  • Subjects known or suspected to have an allergy to medications used during general anesthesia;
  • Subjects receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg2+; based on the dose and time of administration;
  • Pregnant or lactating females;
  • Female subjects of childbearing potential not using any birth control or using only hormonal contraception as birth control;
  • Subjects who had already participated in trial CT 19.4.312, or in another trial with Org 25959;
  • Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00559468     History of Changes
Other Study ID Numbers: P05949, 19.4.312
Study First Received: November 14, 2007
Last Updated: May 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on July 22, 2014