Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

NCT00355368 | Completed Phase 4 Results DMC

• 1 other identifier: EK 145/05
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Haemodynamic Sequelae of Intubation

  between start of induction sequence and 5 min after completion of intubation

• 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.

  during laryngoscopy and the first minute after completion of intubation

• Number of Participants With an Failed First Intubation Attempts

  within the first 90 sec following the start of induction

Study Arms (2)

Succinylcholine

ACTIVE COMPARATOR

Drug: Succinylcholine

Rocuronium

ACTIVE COMPARATOR

Drug: Rocuronium

Interventions

Succinylcholine DRUG

1mg/kg iv

Succinylcholine

Rocuronium DRUG

0.6mg/kg iv

Rocuronium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for emergency intubation in intensive care
• availability of qualified study physician

You may not qualify if:

• contraindication against succinylcholine or rocuronium
• indication for awake fibreoptic intubation

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Medical Intensive Care; University of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 16243994 BACKGROUND

• 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.

  PMID: 21846380 DERIVED

MeSH Terms

Interventions

Succinylcholine; Rocuronium

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Stephan Marsch
• Organization: Medical Intensive care unit, University Hospital Basel

smarsch@uhbs.ch

+ 41 61 265 2525

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Medical ICU

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: August 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: July 1, 2010
• Last Updated: December 15, 2011
• Results First Posted: December 15, 2011

Record last verified: 2011-11

Locations

CH (1)