Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Primary Purpose
Intubation
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Succinylcholine
Rocuronium
Sponsored by

About this trial
This is an interventional treatment trial for Intubation focused on measuring intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents
Eligibility 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
Sites / Locations
- Department of Medical Intensive Care; University of Basel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Succinylcholine
Rocuronium
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Exhibiting Desaturation >5%
decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
Secondary Outcome Measures
Haemodynamic Sequelae of Intubation
any new haemodynamic alteration requiring immediate intervention
Time to Completion of Intubation
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.
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
defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt
Full Information
NCT ID
NCT00355368
First Posted
July 20, 2006
Last Updated
November 10, 2011
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00355368
Brief Title
Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
Official Title
Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation
Keywords
intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Succinylcholine
Arm Type
Active Comparator
Arm Title
Rocuronium
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Succinylcholine
Intervention Description
1mg/kg iv
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
0.6mg/kg iv
Primary Outcome Measure Information:
Title
Number of Participants Exhibiting Desaturation >5%
Description
decrease of >5% in oxygen saturation measured continuously using pulse oxymetry
Time Frame
at any time between the start of the intubation sequence and 2min after the completion of intubation
Secondary Outcome Measure Information:
Title
Haemodynamic Sequelae of Intubation
Description
any new haemodynamic alteration requiring immediate intervention
Time Frame
between start of induction sequence and 5 min after completion of intubation
Title
Time to Completion of Intubation
Description
time interval between the injection of the induction agent and the first appearance of endtidal CO2
Time Frame
time interval between the injection of the induction agent and the first appearance of endtidal CO2
Title
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.
Description
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
Time Frame
during laryngoscopy and the first minute after completion of intubation
Title
Number of Participants With an Failed First Intubation Attempts
Description
defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt
Time Frame
within the first 90 sec following the start of induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Siegemund, MD
Organizational Affiliation
Department of Surgical Intensive Care, University of Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan C Marsch, MD, DPhil
Organizational Affiliation
Department of Medical Intensive Care, University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Intensive Care; University of Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
16243994
Citation
Sluga M, Ummenhofer W, Studer W, Siegemund M, Marsch SC. Rocuronium versus succinylcholine for rapid sequence induction of anesthesia and endotracheal intubation: a prospective, randomized trial in emergent cases. Anesth Analg. 2005 Nov;101(5):1356-1361. doi: 10.1213/01.ANE.0000180196.58567.FE.
Results Reference
background
PubMed Identifier
21846380
Citation
Marsch SC, Steiner L, Bucher E, Pargger H, Schumann M, Aebi T, Hunziker PR, Siegemund M. Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial. Crit Care. 2011 Aug 16;15(4):R199. doi: 10.1186/cc10367.
Results Reference
derived
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Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care
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