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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: Sugammadex; Drug: Rocuronium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475215

MK-8616-017 (Other Identifier)

19.4.308 (Other Identifier)

P05932 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Rocuronium + Sugammadex 2.0 mg/kg

Experimental group

Description:

After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg.

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Rocuronium + Sugammadex 4.0 mg/kg

Experimental group

Description:

After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg.

Treatment:

Drug: Rocuronium

Drug: Sugammadex