Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00535496
First received: September 25, 2007
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: May 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuromuscular Blockade
Intervention: Drug: sugammadex

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.

Participant Flow:   Overall Study
    Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm     Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm     Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm     Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm  
STARTED     15     15     30     31  
All-Subjects-Treated (AST) Group     15     14     30     31  
COMPLETED     15     13     30     31  
NOT COMPLETED     0     2     0     0  
Lost to Follow-up                 0                 1                 0                 0  
Not treated with sugammadex                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sugammadex 1.0 mg/kg Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
Sugammadex 4.0 mg/kg Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
Total Total of all reporting groups

Baseline Measures
    Sugammadex 1.0 mg/kg     Sugammadex 4.0 mg/kg     Total  
Number of Participants  
[units: participants]
  29     61     90  
Age [1]
[units: years]
Mean ± Standard Deviation
  43  ± 11     42  ± 13     42  ± 12  
Gender [1]
[units: participants]
     
Female     16     40     56  
Male     13     21     34  
[1] Randomization into dominant and non-dominant forearms was aimed at preventing bias; so differences between dominant and non-dominant forearms were not analyzed.



  Outcome Measures
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1.  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   [ Time Frame: Up to 4 minutes after administering sugammadex ]

2.  Primary:   Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)   [ Time Frame: up to 2 minutes after administering sugammadex ]

3.  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   [ Time Frame: Up to 3 minutes after administering sugammadex ]

4.  Other Pre-specified:   Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX   [ Time Frame: Up to 150 minutes after administering sugammadex ]

5.  Other Pre-specified:   Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX   [ Time Frame: Up to 7 minutes after administering sugammadex ]

6.  Other Pre-specified:   Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS   [ Time Frame: Up to 5 minutes after administering sugammadex ]

7.  Other Pre-specified:   Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.8 Measured by a TOF-Watch® SX   [ Time Frame: Up to 42 minutes after administering sugammadex ]

8.  Other Pre-specified:   Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.7 Measured by a TOF-Watch® SX   [ Time Frame: Up to 42 minutes after administering sugammadex ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535496     History of Changes
Other Study ID Numbers: P05698, 19.4.313
Study First Received: September 25, 2007
Results First Received: May 1, 2013
Last Updated: March 13, 2014
Health Authority: Sweden: Medical Products Agency