Org 25969 After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (19.4.312)(P05949)(COMPLETED)

Condition(s) targeted: Anesthesia, General

Intervention: Sugammadex (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4. 0 mg. kg-1 Org 25969, administered at T1 3-10% after continuous infusion of rocuronium, between subjects receiving maintenance anesthesia using propofol and subjects receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in subjects after continuous infusion of rocuronium and before the administration of Org 25969, under either propofol or sevoflurane anesthesia.

Official title: A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Org 25969, Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane

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 administration of Org 25969 to recovery T4/T1 ratio to 0.9

Secondary outcome:

Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.9

Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.7

Time from start administration of Org 25969 to recovery T4/T1 ratio to 0.8

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

Criteria:

Inclusion Criteria:

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

- Subjects of ASA class 1-3;

- Subjects scheduled for a surgical procedure under general anesthesia requiring

neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;

- Subjects scheduled for a surgical procedure in supine position;

- Subjects who had given written informed consent.

Exclusion Criteria:

- Subjects in whom difficult intubation was expected because of anatomical

malformations;

- Subjects known or suspected to have neuromuscular disorders affecting NMB and/or

significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;

- Subjects known or suspected to have a (family) history of malignant hyperthermia;

- Subjects known or suspected to have an allergy to medications used during general

anesthesia;

- Subjects receiving medication interfering with NMBAs, such as antibiotics,

anticonvulsants and Mg2+; based on the dose and time of administration;

- Pregnant or lactating females;

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

hormonal contraception as birth control;

- Subjects who had already participated in trial CT 19. 4.312, or in another trial with

Org 25959;

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

within 30 days of entering into CT 19. 4.312.

Starting date: December 2006
Last updated: May 5, 2015