Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)
NCT00473694 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2019-03-19
Summary
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
Conditions
- Anesthesia, General
Interventions
- DRUG
-
sugammadex
Administered as an intravenous (IV) infusion
- DRUG
-
neostigmine
Administered as an IV infusion
- DRUG
-
vecuronium
Administered as an IV infusion
- DRUG
-
rocuronium
Administered as an IV infusion
- DRUG
-
glycopyrrolate
Administered as an IV infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-28
- Primary Completion
- 2006-11-06
- Completion
- 2007-01-29
- FDA Drug
- Yes
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