Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

November 10, 2011 updated by: Stephan Marsch, University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • Department of Medical Intensive Care; University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Succinylcholine
Drug: Succinylcholine
1mg/kg iv
ACTIVE_COMPARATOR: Rocuronium
Drug: Rocuronium
0.6mg/kg iv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemodynamic Sequelae of Intubation
Time Frame: between start of induction sequence and 5 min after completion of intubation
any new haemodynamic alteration requiring immediate intervention
between start of induction sequence and 5 min after completion of intubation
Time to Completion of Intubation
Time Frame: 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
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

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
Number of Participants With an Failed First Intubation Attempts
Time Frame: within the first 90 sec following the start of induction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

August 1, 2006

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 20, 2006

First Posted (ESTIMATE)

July 21, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2011

Last Update Submitted That Met QC Criteria

November 10, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 145/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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