The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9.
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 of up to 1.0) indicates the extent of recovery from neuromuscular blockade (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: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.7
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 of up to 1.0) 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: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.7
Time From Start of Administration of Sugammadex or Neostigmine to Recovery of the T4/T1 Ratio to 0.8
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 of up to 1.0) 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.
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Time frame: Day 1: From start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.8
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Transfer to the Recovery Room After Extubation
After anesthesia and prior to transfer to the recovery room after extubation, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1
Number of Participants With Clinical Signs of Recovery Assessed by Level of Consciousness, Head Lift and Muscle Weakness, Prior to Discharge From the Recovery Room
Just prior to discharge from the recovery room, neuromuscular recovery was assessed by monitoring every 15 minutes the following clinical signs of recovery: level of consciousness (i.e., awake and oriented, arousable with minimal stimulation, responsive only to tactile stimulation); 5-second head lift test (ability to lift the head for 5 seconds); and general muscle weakness
Time frame: Day 1