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Completed

NCT Number: NCT00355368

Succinylcholine Versus Rocuronium 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.

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Key information

Conditions

Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medical Intensive Care; University of Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Succinylcholine

Drug

1mg/kg iv

Rocuronium

Drug

0.6mg/kg iv

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2010
First posted
Jul 21, 2006
Registry last updated
Dec 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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