Org 25969 After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (19.4.312)(P05949)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00559468
First received: November 14, 2007
Last updated: October 2, 2009
Last verified: October 2009
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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 Schering-Plough:
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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More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00559468 History of Changes |
| Other Study ID Numbers: | 19.4.312 |
| Study First Received: | November 14, 2007 |
| Last Updated: | October 2, 2009 |
| 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 May 23, 2013