Succinylcholine Versus Rocuronium for Emergency Intubation in Intensive Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intubation

Intervention / Treatment
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* Drug: Succinylcholine
* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Succinylcholine<br> | Drug: Succinylcholine<br>* 1mg/kg iv<br>|
| Active Comparator: Rocuronium<br> | Drug: Rocuronium<br>* 0.6mg/kg iv<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic Sequelae 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 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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, intensive care, neuromuscular depolarizing agents, neuromuscular nondepolarizing agents, neuromuscular blocking agents