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
  Purpose

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.


Condition Intervention Phase
Intubation
Drug: Succinylcholine
Drug: Rocuronium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 420
Study Start Date: August 2006
Study Completion Date: July 2010
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Succinylcholine Drug: Succinylcholine
1mg/kg iv
Active Comparator: Rocuronium Drug: Rocuronium
0.6mg/kg iv

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355368

Locations
Switzerland
Department of Medical Intensive Care; University of Basel
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephan Marsch, Professor and Chairman of Medical ICU, 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

Keywords provided by University Hospital, Basel, Switzerland:
intubation
intensive care
neuromuscular depolarizing agents
neuromuscular nondepolarizing agents
neuromuscular blocking agents

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Neuromuscular Nondepolarizing Agents
Rocuronium
Succinylcholine
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014