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)

NCT00475215 | Completed Phase 3 Results

• 3 other identifiers: P0593219.4.308MK-8616-017
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (3)

• 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

  The mean time from the start of sugammadex administration to recovery of the T4/T1 ratio to 0.9 was determined. Less time indicates faster recovery from neuromuscular blockade. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four \[TOF\] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.

  Up to 90 minutes

• Percentage of Participants Experiencing ≥1 Adverse Event(s) (AE)

  The percentage of participants experiencing ≥1 AE(s) was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to 7 days

• Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)

  The percentage of participants discontinuing from study treatment due to an AE was determined for each arm. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  Up to 7 days

Secondary Outcomes (8)

• 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

  Up to 90 minutes

• 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

  Up to 90 minutes

• Level of Consciousness Assessment 1: Prior to Transfer to the Recovery Room Following Extubation

  Up to 6 hours (prior to transfer to the recovery room after extubation)

• Level of Consciousness Assessment 2: Prior to Discharge From the Recovery Room

  Up to 6 hours (prior to discharge from the recovery room)

• Five-Second Head Lift Assessment 1: Prior to Transfer to the Recovery Room Following Extubation

  Up to 6 hours (prior to transfer to the recovery room after extubation)

Study Arms (2)

Rocuronium + Sugammadex 2.0 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex; Drug: Rocuronium

Rocuronium + Sugammadex 4.0 mg/kg

EXPERIMENTAL

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.

Drug: Sugammadex; Drug: Rocuronium

Interventions

Sugammadex DRUG

Sugammadex solution for injection.

Also known as: Org 25969, MK-8616, Bridion®

Rocuronium + Sugammadex 2.0 mg/kg; Rocuronium + Sugammadex 4.0 mg/kg

Rocuronium DRUG

Rocuronium bromide solution for injection.

Also known as: Zemuron®

Rocuronium + Sugammadex 2.0 mg/kg; Rocuronium + Sugammadex 4.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 22608583 DERIVED

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Interventions

Sugammadex; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: October 27, 2005
• Primary Completion: August 21, 2006
• Study Completion: September 9, 2006
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04