Clinical trial NCT00475215: 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)
Official title: A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.9 in Participants With or Having a Past History of Pulmonary Disease
timeFrame: Up to 90 minutes
measure: Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)
timeFrame: Up to 7 days
measure: Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.7 in Participants With or Having a Past History of Pulmonary Disease
timeFrame: Up to 90 minutes
measure: Time From Start of Sugammadex Administration to Recovery of T4/T1 Ratio to 0.8 in Participants With or Having a Past History of Pulmonary Disease
timeFrame: Up to 90 minutes
measure: Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
timeFrame: Up to 6 hours (prior to transfer to the recovery room after extubation)
measure: Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room
timeFrame: Up to 6 hours (prior to discharge from the recovery room)
measure: Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
timeFrame: Up to 6 hours (prior to transfer to the recovery room after extubation)
measure: Five-Second Head Lift Assessment 2: Prior to Discharge From the Recovery Room
timeFrame: Up to 6 hours (prior to discharge from the recovery room)
measure: General Muscle Weakness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation
timeFrame: Up to 6 hours (prior to transfer to the recovery room after extubation)
measure: General Muscle Weakness Assessment 2: Prior to Discharge From the Recovery Room
timeFrame: Up to 6 hours (prior to discharge from the recovery room)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Amao R, Zornow MH, Cowan RM, Cheng DC, Morte JB, Allard MW. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012 Jun;24(4):289-97. doi: 10.1016/j.jclinane.2011.09.006.