Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)

• Status: Completed
• Trial end date: 2004-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Rocuronium

Criteria

Inclusion Criteria:

• Participants of ASA class 1 - 3, above or equal to the age of 18 years;

• Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 120 minutes, without further need for muscle relaxation other than for intubation;

• Participants scheduled for surgical procedures in supine position;

• Participants who had given written informed consent.

Exclusion Criteria:

• Participants in whom a difficult intubation because of anatomical malformations was expected;

• Participants known or suspected to have neuromuscular disorders impairing neuromuscular blocking and/or significant renal dysfunction;

• Participants known or suspected to have a (family) history of malignant hyperthermia;

• Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;

• Participants receiving medication known to interfere with neuromuscular blocking agents, such as anticonvulsants and Mg^2+;

• Participants who had already participated in this trial;

• Participants who had participated in another clinical trial, not pre-approved by the Sponsor, within 30 days of entering into this trial;

• Female participants who were pregnant: in females, pregnancy was to be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who were not of childbearing potential, i.e. at least 2 years menopausal or who had undergone tubal ligation or an hysterectomy;

• Female participants of childbearing potential not using any of the following methods of birth control (for one month): condom or diaphragm with spermicide, vasectomized partner (>6 months), intrauterine device (IUD), abstinence;

• Female participants who were breast-feeding.