Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
Status and phase
Completed
Phase 3
Conditions
Anesthesia, General
Treatments
Drug: Sugammadex
Drug: Rocurium
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
162 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
162 participants in 3 patient groups
Participants 18 to 64 years old
Experimental group
Description:
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.
Treatment:
Drug: Rocurium
Drug: Sugammadex
Participants 65 to 74 years old
Experimental group
Description:
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.
Treatment:
Drug: Rocurium
Drug: Sugammadex
Participants 75 years and older
Experimental group
Description:
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.
Treatment:
Drug: Rocurium
Drug: Sugammadex
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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