Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephan Marsch, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00355368
First received: July 20, 2006
Last updated: November 10, 2011
Last verified: November 2011
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Intubation
Interventions: Drug: Succinylcholine
Drug: Rocuronium

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Succinylcholine 1mg/kg
Rocuronium 0.6mg/kg

Participant Flow:   Overall Study
    Succinylcholine     Rocuronium  
STARTED     210     210  
COMPLETED     200     201  
NOT COMPLETED     10     9  
Protocol Violation                 8                 7  
cardiac arrest prior to intubation                 2                 2  



  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
Succinylcholine 1mg/kg
Rocuronium 0.6mg/kg
Total Total of all reporting groups

Baseline Measures
    Succinylcholine     Rocuronium     Total  
Number of Participants  
[units: participants]
  210     210     420  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     123     108     231  
>=65 years     87     102     189  
Age  
[units: years]
Mean ± Standard Deviation
  60  ± 16     63  ± 14     61  ± 15  
Gender  
[units: participants]
     
Female     91     93     184  
Male     119     117     236  
Region of Enrollment  
[units: participants]
     
Switzerland     210     210     420  



  Outcome Measures
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1.  Primary:   Number of Participants Exhibiting Desaturation >5%   [ Time Frame: at any time between the start of the intubation sequence and 2min after the completion of intubation ]

2.  Secondary:   Time to Completion of Intubation   [ Time Frame: time interval between the injection of the induction agent and the first appearance of endtidal CO2 ]

3.  Secondary:   Quality of Intubation Conditions Using a Validated Score: Viby-Mogensen et al. Good Clinical Research Practice (GCRP) in Pharmacodynamic Studies of Neuromuscular Blocking Agents. Acta Anaesthesiol Scand 1996;40:59-74.   [ Time Frame: during laryngoscopy and the first minute after completion of intubation ]

4.  Secondary:   Number of Participants With an Failed First Intubation Attempts   [ Time Frame: within the first 90 sec following the start of induction ]

5.  Secondary:   Haemodynamic Sequelae of Intubation   [ Time Frame: between start of induction sequence and 5 min after completion of intubation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


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  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephan Marsch
Organization: Medical Intensive care unit, University Hospital Basel
phone: + 41 61 265 2525
e-mail: smarsch@uhbs.ch


Publications:
Publications automatically indexed to this study:

Responsible Party: Stephan Marsch, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00355368     History of Changes
Other Study ID Numbers: EK 145/05
Study First Received: July 20, 2006
Results First Received: August 8, 2011
Last Updated: November 10, 2011
Health Authority: Switzerland: Swissmedic