Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care - Full Text View

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:

Drug Information available for: Succinylcholine chloride Rocuronium bromide Rocuronium

U.S. FDA Resources

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

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:

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):1356-61.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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 May 19, 2013