Comparison of Org 25969 With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (19.4.301)(P05960)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia, General
Intervention: Sugammadex (Drug); neostigmine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The purpose of this study was to demonstrate in adult patients faster recovery from a
neuromuscular block induced by either rocuronium or vecuronium after reversal at
reappearance of T2 by 2. 0 mg/kg Org 25969 (sugammadex) compared to 50 ug/kg neostigmine.
Clinical Details
Official title: A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time from start administration of Org 25969/neostigmine to recovery T4/T1 ratio to 0.9.
Secondary outcome: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects of ASA 1 - 4;
- Subjects above or equal to the age of 18;
- Scheduled for surgical procedures with a general anesthesia with the use of
rocuronium or vecuronium for endotracheal intubation and maintenance of neuromuscular
block;
- Scheduled for surgical procedure in supine position;
- Given written informed consent.
Exclusion Criteria:
- Subjects in whom a difficult intubation because of anatomical malformations was
expected;
- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular
block (NMB) 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 medication used during general anesthesia;
- Subjects receiving medication in a dose and/or at a time point known to interfere
with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+;
- Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
- Subjects who had already participated in an Org 25969 trial;
- Subjects who had participated in another clinical trial, not pre-approved by NV
Organon, within 30 days of entering into CT 19. 4.301.
- Female subjects who are pregnant:
- Female subjects of childbearing potential not using any method of birth control:
condom or using only hormonal contraception as birth control;
- Female subjects who were breast-feeding.
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: February 10, 2015
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