Clinical trial NCT00474617: Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
Official title: A Multicenter, Parallel Group, Comparative, Phase IIIa Trial to Compare the Efficacy, Safety, and Pharmacokinetics of Org 25969 in Elderly Subjects With Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 to 3
* 18 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.9
timeFrame: up to 10 minutes from start of sugammadex
Secondary outcomes:
measure: Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
timeFrame: up to 10 minutes from start of sugammadex
measure: Mean Time From Start of Administration of to Recovery of the T4/T1 Ratio to 0.8
timeFrame: up to 10 minutes from start of sugammadex
measure: Participants Level of Consciousness Prior to Transfer to the Recovery Room After Extubation
timeFrame: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
measure: Participants Level of Consciousness Prior to Discharge From Recovery Room
timeFrame: Prior to Discharge from Recovery Room (up to 24 hours)
measure: Number of Participants With General Muscle Weakness Prior to Transfer to the Recovery Room After Extubation
timeFrame: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
measure: Number of Participants With General Muscle Weakness Prior to Discharge From Recovery Room
timeFrame: Prior to Discharge from Recovery Room (up to 24 hours)
measure: Number of Participants Who Can Perform a 5 Second Head Lift Prior to Transfer to the Recovery Room After Extubation
timeFrame: Prior to Transfer to the Recovery Room After Extubation (up to 24 hours)
measure: Number of Participants Who Can Perform a 5 Second Head Lift Prior to Discharge From Recovery Room
timeFrame: Prior to Discharge from Recovery Room (up to 24 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.