ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00559468
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Anesthesia, General Drug: Sugammadex Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Actual Study Start Date : December 7, 2006
Actual Primary Completion Date : March 2, 2007
Actual Study Completion Date : March 2, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ]

Secondary Outcome Measures :
  1. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ]
  2. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7 [ Time Frame: After surgery ]
  3. Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.8 [ Time Frame: After surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00559468     History of Changes
Other Study ID Numbers: P05949
19.4.312
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

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