Comparison of Sugammadex With Neostigmine Administered at 1-2 PTCs After Administration of Rocuronium or Vecuronium (19.4.302)(P05945)
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|ClinicalTrials.gov Identifier: NCT00473694|
Recruitment Status : Completed
First Posted : May 15, 2007
Last Update Posted : August 22, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Anesthesia, General||Drug: sugammadex Drug: neostigmine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 28, 2005|
|Primary Completion Date :||November 6, 2006|
|Study Completion Date :||January 29, 2007|
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
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.
Primary Outcome Measures :
- Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9 [ Time Frame: After surgery ]
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 ]
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