A Bridging Trial Comparing Org 25969 at Reappearance of T2 in Japanese and Caucasian Subjects. Part B: Caucasian Subjects (19.4.208B)(P05971)(COMPLETED)

Condition(s) targeted: Anesthesia, General

Intervention: sugammadex (Org 25969) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

The objective of the trial was to establish the dose-response relation of Org 25969 given as a reversal agent of rocuronium or vecuronium at reappearance of T2 during sevoflurane anesthesia for Caucasian subjects.

Official title: A Multi-Center, Randomized, Open-Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 4 Doses of Org 25969 and Placebo Administered at Reappearance of T2 After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.9

Secondary outcome: Time from start of administration of Org 25969 / placebo to recovery of the T4/T1 ratio to 0.7 and 0.8

Detailed description: For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to reverse the neuromuscular block. Org 25969 has been shown in previous trials to greatly reduce the time to full recovery when administered at reappearance of T2, both after rocuronium- and vecuronium induced neuromuscular blockade. The current trial 19. 4.208B was conducted in Europe and set up to establish the doseresponse relationship of Org 25969 given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in Caucasian subjects. In addition to recovery time, also pharmacokinetics and safety of Org 25969 were to be evaluated.

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects of ASA class 1 - 3;

- Subjects at least 20 years but under 65 years of age;

- Caucasian subjects;

- Subjects scheduled for elective surgery requiring muscle relaxation in supine

position and under sevoflurane anesthesia with an anticipated duration of about 1. 5-3 hours;

- Subjects who had 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 NMB and/or

significant renal dysfunction (for example a creatinine level > 1. 6 mg/dl) and/or severe hepatic 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 expected to interfere with the rocuronium or vecuronium

given in this trial, based on the dose and time of administration;

- Female subjects who were pregnant;

- Female subjects of childbearing potential not using birth control or using only oral

contraception as birth control;

- Subjects who were breast-feeding;

- Subjects who had already participated in CT 19. 4.208B, or in another trial with Org

25969;

- Subjects who had participated in another clinical trial, not preapproved by Organon,

within 6 months of entering into CT 19. 4.208B.

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