Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

• Status: Completed
• Trial end date: 2006-09-09
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class 1 to 3;

• Has been diagnosed with or having a past history of pulmonary disease;

• Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;

• Is scheduled for surgery in supine position;

• Has given written informed consent;

Exclusion Criteria:

• Is expected to have a difficult intubation due to anatomical malformations;

• Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;

• Has known or suspected of having a (family) history of malignant hyperthermia;

• Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;

• Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;

• Is a female who is pregnant or breast-feeding;

• Is a female of childbearing potential not using an acceptable method of birth control [condom or diaphragm with spermicide, vasectomized partner (> 6 months), IUD, abstinence] or using only hormonal contraception as birth control;

• Has already participated in a sugammadex trial including Protocol 19.4.308;

• Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.