Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

NCT00474617 | Completed Phase 3 Results

• 3 other identifiers: P0595019.4.305MK-8616-029
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9

  Neuromuscular function was monitored by applying repetitive train-of-four (TOF) electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery.

  up to 10 minutes from start of sugammadex

Secondary Outcomes (8)

• Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7

  up to 10 minutes from start of sugammadex

• Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8

  up to 10 minutes from start of sugammadex

• Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation

  Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

• Participants Level of Consciousness Prior to Discharge From Recovery Room

  Prior to Discharge from Recovery Room (up to 24 hours)

• Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation

  Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)

Study Arms (3)

Participants 18 to 64 years old

EXPERIMENTAL

Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Drug: Sugammadex; Drug: Rocurium

Participants 65 to 74 years old

EXPERIMENTAL

Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Drug: Sugammadex; Drug: Rocurium

Participants 75 years and older

EXPERIMENTAL

Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Drug: Sugammadex; Drug: Rocurium

Interventions

Sugammadex DRUG

Also known as: Org 25969; MK-8616

Participants 18 to 64 years old; Participants 65 to 74 years old; Participants 75 years and older

Rocurium DRUG

intravenous (IV) single bolus dose of 0.6 mg.kg-1

Participants 18 to 64 years old; Participants 65 to 74 years old; Participants 75 years and older

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
• years of age or older
• Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
• Scheduled for surgery in supine position
• Given written informed consent

You may not qualify if:

• Participants in whom a difficult intubation is expected due to anatomical malformations
• Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade 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 medications used during surgery
• Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
• Female participants who are pregnant or breast-feeding
• Females participants of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), intrauterine device (IUD), abstinence\]
• Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
• Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• McDonagh DL, Benedict PE, Kovac AL, Drover DR, Brister NW, Morte JB, Monk TG. Efficacy, safety, and pharmacokinetics of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in elderly patients. Anesthesiology. 2011 Feb;114(2):318-29. doi: 10.1097/ALN.0b013e3182065c36.

  PMID: 21239968 RESULT

Related Links

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

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 17, 2007
• Study Start: December 29, 2005
• Primary Completion: October 20, 2006
• Study Completion: October 20, 2006
• Last Updated: April 2, 2019
• Results First Posted: March 25, 2019

Record last verified: 2019-03