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Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (COMPLETED)(P05698)
This study has been completed.

First Received on September 25, 2007.   Last Updated on October 2, 2009   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00535496
  Purpose

The objective of the trial is to determine the relation within a subject between the time to manual detection of the reappearance of T4 measured using a peripheral nerve stimulator (PNS) and the time to recovery of the T4/T1 ratio to 0.9 measured using a TOF-Watch® SX, of 4.0 mg.kg-1 sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg.kg-1 rocuronium or the last maintenance dose of 0.15 mg.kg-1 rocuronium


Condition Intervention Phase
Anesthesia, General
 Drug: sugammadex
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the T4/T1 Ratio Measured by Means of the TOF Watch® SX With the Reappearance of T4 Measured by Means of a Peripheral Nerve Stimulator in Adult Subjects Receiving 4.0 mg.Kg-1 Sugammadex at 15 Minutes After Rocuronium

Resource links provided by NLM:

Drug Information available for: Sugammadex Sugammadex Sodium
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Time from start administration of 4.0 mg.kg-1 sugammadex to recovery of the T4/T1 ratio to 0.9 (TOF-Watch® SX) [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Time from start administration of 4.0 mg.kg-1 sugammadex to reappearance of T4 (Peripheral Nerve Stimulator). [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from start administration of 1.0 mg.kg-1 sugammadex to recovery of the T4/T1 ratio to 0.9 (TOF-Watch® SX) [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Time from start administration of 1.0 and 4.0 mg.kg-1 sugammadex to reappearance of T4 (TOF-Watch® SX) [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Time from start administration of 1.0 mg.kg-1 sugammadex to reappearance of T4 (Peripheral Nerve Stimulator) [ Time Frame: after surgery ] [ Designated as safety issue: No ]
  • Time from start administration of 1.0 and 4.0 mg.kg-1 sugammadex to recovery of the T4/T1 ratio to 0.7, T4/T1 ratio to 0.8 (TOF-Watch® SX) [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
sugammadex 1.0 mg/kg, TOF-Watch SX (dominant forearm) and PNS (non-dominant forearm)
 Drug: sugammadex
IV bolus dose
Other Name: Org 25969
Experimental: 2
sugammadex 1.0 mg/kg, TOF-Watch SX (non-dominant forearm) and PNS (dominant forearm)
 Drug: sugammadex
IV bolus dose
Other Name: Org 25969
Experimental: 3
sugammadex 4.0 mg/kg, TOF-Watch SX (dominant forearm) and PNS (non-dominant forearm)
 Drug: sugammadex
IV bolus dose
Other Name: Org 25969
Experimental: 4
sugammadex 4.0 mg/kg, TOF-Watch SX (non-dominant forearm) and PNS (dominant forearm)
 Drug: sugammadex
IV bolus dose
Other Name: Org 25969

Detailed Description:

So far, the TOF-Watch® SX has been used for neuromuscular monitoring in all clinical trials with sugammadex. In clinical practice however, a PNS is commonly used in many hospitals worldwide. A disadvantage of the use of a PNS is that it is not objective monitoring like the TOF-Watch® SX and that only the number of twitches that are present can be detected with it. In this trial, a correlation between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX will be determined after a dose of 4.0 mg.kg-1 sugammadex administered 15 minutes after the last dose of rocuronium. This correlation enables to provide an advice on when it is safe to extubate a patient after administration of 4.0 mg.kg-1 sugammadex for reversal of neuromuscular block while using a PNS. The time to reappearance of T4 is being assessed by a blinded PNS-assessor. This person will be blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects:

    • of 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 procedures in supine position;
    • who have given written informed consent.

Exclusion Criteria:

  • Subjects in whom a difficult intubation because of anatomical malformations is expected;
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic and/or renal dysfunction;
  • Subjects with a medical or physical condition that is expected to interfere with the proper conduct of simultaneous neuromuscular monitoring on both arms;
  • Subjects known or suspected to have a (family) history of malignant hyperthermia;
  • Subjects known or suspected to have arthritis or another disease that will cause the thumb not to move freely;
  • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
  • Subjects receiving medication in a dose and/or at a time point known to interfere with NMBAs, such as antibiotics, anticonvulsants and Mg2+;
  • Subjects who have already participated in a sugammadex trial;
  • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.313;
  • Female subjects who are pregnant;
  • Female subjects who are breast-feeding.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00535496     History of Changes
Other Study ID Numbers: 19.4.313, P05698
Study First Received: September 25, 2007
Last Updated: October 2, 2009
Health Authority: Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on February 09, 2012



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