Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

Intubation Clinical Trial

Official title:

Phase 4 Study of Succinylcholine Versus Rocuronium as Neuromuscular Blocking Agent for Emergency Intubation in Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355368
• Other study ID #: EK 145/05
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2006
• Last updated: November 10, 2011
• Start date: August 2006
• Est. completion date: July 2010

Study information

• Verified date: November 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 2010
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation

Intervention

Drug:
• Succinylcholine
1mg/kg iv
• Rocuronium
0.6mg/kg iv

Locations

Country	Name	City	State
Switzerland	Department of Medical Intensive Care; University of Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Exhibiting Desaturation >5%	decrease of >5% in oxygen saturation measured continuously using pulse oxymetry	at any time between the start of the intubation sequence and 2min after the completion of intubation	Yes
Secondary	Haemodynamic Sequelae of Intubation	any new haemodynamic alteration requiring immediate intervention	between start of induction sequence and 5 min after completion of intubation	Yes
Secondary	Time to Completion of Intubation	time interval between the injection of the induction agent and the first appearance of endtidal CO2	time interval between the injection of the induction agent and the first appearance of endtidal CO2	No
Secondary	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	during laryngoscopy and the first minute after completion of intubation	No
Secondary	Number of Participants With an Failed First Intubation Attempts	defined as either uncompleted intubation attempt within 90 sec or starting a second intubation attempt	within the first 90 sec following the start of induction	No