Sugammadex
DrugSingle dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
Other names: Org 25969, MK-8616
NCT Number: NCT00559468
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.
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Notify Me20 year–65 year
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
Other names: Org 25969, MK-8616
Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
Other names: Esmeron®, Rocuronium Bromide
Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
Other names: Ultane®
Propofol IV administered for induction and maintenance of anesthesia, based on randomization.
Other names: Diprivan®
Time frame: Up to 3 minutes after sugammadex administration
Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached >= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.
Time frame: Up to 3 minutes after sugammadex administration
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.7 indicates a faster recovery from NMB.
Time frame: Up to 3 minutes after sugammadex administration
Neuromuscular functioning was monitored by applying repetitive TOF electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 [loss of T4] up to 1.0 [no NMB]) indicates the extent of recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.8 indicates a faster recovery from NMB.
Merck Sharp & Dohme LLC
Industry
A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane
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