Phase 3
Completed N=91
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT00535496 ↗
Enrolled (actual)
91
Serious AEs
3.3%
Results posted
Sep 2013
Primary outcomePrimary: Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX — 1.5 Minutes
Summary
The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX |
1.5 | — |
| PRIMARY Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS) |
0.8 | — |
| PRIMARY Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex |
0.8 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
- between the ages of 18 to 64 years, inclusive
- scheduled for a surgical procedure under general anesthesia requiring
neuromuscular relaxation with the use of rocuronium
- scheduled for a surgical procedure in supine position
- have given written informed consent
Exclusion Criteria
- participants with a difficult intubation because of expected anatomical
malformations
- known or suspected to have neuromuscular disorders impairing
neuromuscular blockade and/or significant hepatic and/or renal
dysfunction
- medical or physical condition that is expected to interfere
with the proper conduct of simultaneous neuromuscular monitoring on
both arms
- known or suspected to have a (family) history of malignant
hyperthermia
- known or suspected to have arthritis or another disease that will
cause the thumb not to move freely
- known or suspected to have an allergy to narcotics, muscle
relaxants or other medication used during general anesthesia
- is receiving medication in a dose and/or at a time point known to
interfere with neuromuscular blocking agents (NMBAs), such as antibiotics, anticonvulsants and Mg2+
- already participated in a sugammadex trial
- participated in another clinical trial, not pre-approved, within prior 30 days
- pregnant females
- breast-feeding females
Data sourced from ClinicalTrials.gov (NCT00535496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.