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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
History of Changes

July 20, 2006
November 10, 2011
August 2006
August 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
  • Intubating Score
  • length of intubating sequence
  • failed intubating attempts
Complete list of historical versions of study NCT00355368 on ClinicalTrials.gov Archive Site
  • Haemodynamic Sequelae of Intubation [ Time Frame: between start of induction sequence and 5 min after completion of intubation ] [ Designated as safety issue: Yes ]
    any new haemodynamic alteration requiring immediate intervention
  • Time to Completion of Intubation [ Time Frame: time interval between the injection of the induction agent and the first appearance of endtidal CO2 ] [ Designated as safety issue: No ]
    time interval between the injection of the induction agent and the first appearance of endtidal CO2
  • 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 ] [ Designated as safety issue: No ]

    The factors laryngoscopy, vocal cords, and response to intubation are individually rated with a score from 1 (bad intubation conditions)to 3 (excellent intubation conditions)and the resulting three scores are summed up. The maximum score is thus 9 while the minimum score is 3.

    Units: measure on a scale

  • Number of Participants With an Failed First Intubation Attempts [ Time Frame: within the first 90 sec following the start of induction ] [ Designated as safety issue: No ]
    defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt
  • haemodynamic sequelae of intubation
  • desaturations
Not Provided
Not Provided
 
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care

Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).

Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Intubation
  • Drug: Succinylcholine
    1mg/kg iv
  • Drug: Rocuronium
    0.6mg/kg iv
  • Active Comparator: Succinylcholine
    Intervention: Drug: Succinylcholine
  • Active Comparator: Rocuronium
    Intervention: Drug: Rocuronium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
July 2010
August 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • indication for emergency intubation in intensive care
  • availability of qualified study physician

Exclusion Criteria:

  • contraindication against succinylcholine or rocuronium
  • indication for awake fibreoptic intubation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00355368
EK 145/05
Yes
Stephan Marsch, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Martin Siegemund, MD Department of Surgical Intensive Care, University of Basel
Principal Investigator: Stephan C Marsch, MD, DPhil Department of Medical Intensive Care, University of Basel
University Hospital, Basel, Switzerland
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP