Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)(COMPLETED)

Condition(s) targeted: Anesthesia, General

Intervention: Sugammadex (Drug); neostigmine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

The purpose of this study was to demonstrate in adult patients a faster recovery from a neuromuscular block with 2. 0 mg/kg Org 25969 (sugammadex) after rocuronium as compared to 50 ug/kg neostigmine after cisatracurium when administered at reappearance of T2

Official title: Comparison of Rocuronium and Org25969 With Cisatracurium and Neostigmine When Neuromuscular Block is Reversed 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, and general muscle weakness)

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 requiring neuromuscular

relaxation with the use of rocuronium or cisatracurium;

- Scheduled for surgical procedures 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 Org25969 trial;

- Subjects who had participated in another clinical trial (not pre-approved by NV

Organon) within 30 days of entering into CT 19. 4.310.

- 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.

Starting date: November 2005
Last updated: June 5, 2015