Adults 20 to 65, any sex, with Anesthesia, General. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.9 for Train-Of-Four (TOF) StimulationPrimary· Up to 269:45 (min:sec)
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 f
Group
Value
95% CI
Sugammadex 0.5 mg/kg (Rocuronium)
66.90
± 34.63
Sugammadex 1.0 mg/kg (Rocuronium)
4.73
± 1.73
Sugammadex 2.0 mg/kg (Rocuronium)
3.43
± 2.52
Sugammadex 4.0 mg/kg (Rocuronium)
1.58
± 0.88
Sugammadex 8.0 mg/kg (Rocuronium)
1.32
± 0.57
Sugammadex 0.5 mg/kg (Vecuronium)
79.48
± 46.23
Sugammadex 1.0 mg/kg (Vecuronium)
39.82
± 45.77
Sugammadex 2.0 mg/kg (Vecuronium)
16.02
± 42.20
Sugammadex 4.0 mg/kg (Vecuronium)
3.05
± 2.38
Sugammadex 8.0 mg/kg (Vecuronium)
2.93
± 3.77
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.7 for TOF StimulationSecondary· Up to 152:30 (min:sec)
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.
Group
Value
95% CI
Sugammadex 0.5 mg/kg (Rocuronium)
34.45
± 32.12
Sugammadex 1.0 mg/kg (Rocuronium)
4.38
± 2.32
Sugammadex 2.0 mg/kg (Rocuronium)
2.48
± 2.00
Sugammadex 4.0 mg/kg (Rocuronium)
1.07
± 0.20
Sugammadex 8.0 mg/kg (Rocuronium)
1.03
± 0.32
Sugammadex 0.5 mg/kg (Vecuronium)
56.82
± 35.47
Sugammadex 1.0 mg/kg (Vecuronium)
8.30
± 10.90
Sugammadex 2.0 mg/kg (Vecuronium)
3.18
± 3.72
Sugammadex 4.0 mg/kg (Vecuronium)
1.95
± 1.35
Sugammadex 8.0 mg/kg (Vecuronium)
1.33
± 0.58
Time From Start of Sugammadex Administration to Recovery of the Neuromuscular Response to a Ratio of 0.8 for TOF StimulationSecondary· Up to 194:45 (min:sec)
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.
Group
Value
95% CI
Sugammadex 0.5 mg/kg (Rocuronium)
46.78
± 30.85
Sugammadex 1.0 mg/kg (Rocuronium)
4.33
± 1.85
Sugammadex 2.0 mg/kg (Rocuronium)
2.98
± 2.17
Sugammadex 4.0 mg/kg (Rocuronium)
1.33
± 0.58
Sugammadex 8.0 mg/kg (Rocuronium)
1.13
± 0.40
Sugammadex 0.5 mg/kg (Vecuronium)
73.25
± 45.65
Sugammadex 1.0 mg/kg (Vecuronium)
22.60
± 27.90
Sugammadex 2.0 mg/kg (Vecuronium)
6.02
± 11.83
Sugammadex 4.0 mg/kg (Vecuronium)
2.22
± 1.48
Sugammadex 8.0 mg/kg (Vecuronium)
1.42
± 0.53
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 7 post-operative days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Sugammadex 0.5 mg/kg (Rocuronium)
Serious: 0/9 (0%)
Deaths: 0/9
Sugammadex 1.0 mg/kg (Rocuronium)
Serious: 1/9 (11%)
Deaths: 0/9
Sugammadex 2.0 mg/kg (Rocuronium)
Serious: 0/10 (0%)
Deaths: 0/10
Sugammadex 4.0 mg/kg (Rocuronium)
Serious: 0/11 (0%)
Deaths: 0/11
Sugammadex 8.0 mg/kg (Rocuronium)
Serious: 0/10 (0%)
Deaths: 0/10
Sugammadex 0.5 mg/kg (Vecuronium)
Serious: 0/10 (0%)
Deaths: 0/10
Sugammadex 1.0 mg/kg (Vecuronium)
Serious: 0/10 (0%)
Deaths: 0/10
Sugammadex 2.0 mg/kg (Vecuronium)
Serious: 1/10 (10%)
Deaths: 0/10
Sugammadex 4.0 mg/kg (Vecuronium)
Serious: 1/10 (10%)
Deaths: 0/10
Sugammadex 8.0 mg/kg (Vecuronium)
Serious: 0/10 (0%)
Deaths: 0/10
Serious adverse events (3 terms)
Reaction
System
Sugammadex 0.5 mg/kg (Rocu…
Sugammadex 1.0 mg/kg (Rocu…
Sugammadex 2.0 mg/kg (Rocu…
Sugammadex 4.0 mg/kg (Rocu…
Sugammadex 8.0 mg/kg (Rocu…
Sugammadex 0.5 mg/kg (Vecu…
Sugammadex 1.0 mg/kg (Vecu…
Sugammadex 2.0 mg/kg (Vecu…
Sugammadex 4.0 mg/kg (Vecu…
Sugammadex 8.0 mg/kg (Vecu…
Disseminated intravascular coagulation
Blood and lymphatic system disorders
—
—
—
—
—
—
—
—
—
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
—
—
—
—
—
Retinal detachment
Eye disorders
—
—
—
—
—
—
—
—
—
—
Other adverse events (105 terms — click to expand)
The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at 1-2 PTC during sevoflurane anesthesia for Japanese participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 15 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00591786.