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

Sponsored by:	University Hospital, Basel, Switzerland
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00355368

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 IV

Drug Information available for: Rocuronium ORG 9426 Succinylcholine Succinylcholine chloride Suxamethonium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care

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

Primary Outcome Measures:

intubating score [ Time Frame: 3 min ] [ Designated as safety issue: No ]
length of intubating sequence [ Time Frame: 5 min ] [ Designated as safety issue: No ]
failed intubating attempts [ Time Frame: 10 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

haemodynamic sequelae of intubation [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]
desaturations [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Intervention Details:

1mg/kg iv

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

Contacts

Contact: Stephan C Marsch, MD, DPhil

+4161 2652525

smarsch@uhbs.ch

Locations

Switzerland, BS
Department of Medical Intensive Care; University of Basel	Recruiting
Basel, BS, Switzerland, 4031
Principal Investigator: Stephan C Marsch, MD, DPhil

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.

Study ID Numbers:	EK 145/05
Study First Received:	July 20, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00355368
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:

intubation
intensive care
neuromuscular depolarizing agents
neuromuscular nondepolarizing agents
neuromuscular blocking agents

Study placed in the following topic categories:

Succinylcholine
Rocuronium
Emergencies

Additional relevant MeSH terms:

Neuromuscular Nondepolarizing Agents
Disease Attributes
Pathologic Processes
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents

Neuromuscular Agents
Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009