Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00473694
First received: May 14, 2007
Last updated: October 2, 2009
Last verified: October 2009
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Purpose
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine
| Condition | Intervention | Phase |
|---|---|---|
|
Anesthesia, General |
Drug: sugammadex Drug: neostigmine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Randomized Parallel Group Comparative Active-Controlled Safety-Assessor Blinded Phase 3a, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a NMB Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs |
Resource links provided by NLM:
Drug Information available for:
Neostigmine methylsulfate
Vecuronium bromide
Vecuronium
Rocuronium bromide
Rocuronium
U.S. FDA Resources
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Time from start administration of Org 25969/neostigmine 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/neostigmine to recovery T4/T1 ratio to 0.7 and 0.8; assessment of clinical signs of recovery (level of consciousness, 5-sec head lift, general muscle weakness) [ Time Frame: After surgery ] [ Designated as safety issue: No ]
| Enrollment: | 182 |
| Study Start Date: | November 2005 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sugammadex
|
Drug: sugammadex
Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 4.0 mg/kg Sugammadex (Org 25969) was to be administered.
Other Name: Org 25969
|
|
Active Comparator: 2
neostigmine
|
Drug: neostigmine
Subjects received rocuronium or vecuronium in randomized order with single and maintenance (if applicable) dosing according to local treatment practice. After the last dose of rocuronium or vecuronium, a dose of 70 μg/kg neostigmine was to be administered. A maximum of 5 mg neostigmine was to be administered.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA Class 1 to 4;
- 18 years or older;
- Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block for intubation and maintenance;
- Scheduled for surgery in supine position;
- Given written informed consent;
Exclusion Criteria:
- Subjects in whom a difficult intubation is expected due to anatomical malformations;
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade 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 medications used during surgery;
- Subjects receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
- Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Female subjects who are pregnant or breast-feeding;
- Females subjects of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence];
- Subjects who had already participated in an Org 25969 trial including Protocol 19.4.302;
- Subjects who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.302.
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: | NCT00473694 History of Changes |
| Other Study ID Numbers: | 19.4.302 |
| Study First Received: | May 14, 2007 |
| Last Updated: | October 2, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neostigmine Vecuronium Bromide Rocuronium Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents |
Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Neuromuscular Nondepolarizing Agents Neuromuscular Blocking Agents Neuromuscular Agents Nicotinic Antagonists Cholinergic Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013