Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity

Study Overview
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Brief Summary
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The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.

Detailed Description
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The national recommendations of sedation concerning the intubation in emergency settings advise the use of a hypnotic, etomidate associated to succinylcholine. A national inquiry showed that more than 80% of prehospital intubations use a rapid sequence intubation as sedation. However, several recent studies throw into question the use of etomidate in this indication. Indeed, etomidate is a powerful inhibitor of the synthesis of cortisol. Adrenocortical hormone insufficiency is clearly associated to an increase in the morbidity-mortality of critically ill patients. Several authors advise therefore against the use of etomidate for such patients. Yet, to date, only indirect arguments associating the use of etomidate with excessive morbidity-mortality exist. A real causality link is not yet established. Another hypnotic that could constitute a therapeutic alternative to the use of etomidate exists: ketamine. The advantage of this molecule is that it does not inhibit the adrenocortical hormone axis. Objectives: To evaluate sedation using ketamine versus etomidate in term of morbidity-mortality in critically ill patients intubated in the prehospital setting. Experimental diagram: A prospective, multicentric, randomized, controlled, simple blind trial with independent analysis of the primary outcome. The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation. The risks incurred for patients being suitable to this research are bound essentially to the adverse effects of ketamine. These include some psycho-dyslectic manifestations: nightmare, unpleasant awakening, and disruption of the visual, auditory sensations and mood, a sensation to float and sometimes depersonalization. These adverse effects are warned by a continuous administration of benzodiazepines.

Official Title
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Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity

Conditions
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Intubation; Difficult

Intervention / Treatment
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* Drug: Ketamine
* Drug: Etomidate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring sedation for prehospital endotracheal intubation Age ≥ 18 years Consent of a family member if present, then of the patient for the pursuit of research Exclusion Criteria: Patient in cardiac arrest Presence of contraindication to succinylcholine: Personal or familial history of malignant hyperthermia Known hypersensitivity to succinylcholine Skeletal muscle disease Myasthenia Known hyperkalemia Severe ophthalmic injury Known congenital deficit in plasmatic pseudo-cholinesterase Presence of contraindication to ketamine: Known hypersensitivity to ketamine Known porphyria Severe hypertension Presence of contraindication to etomidate: Known untreated adrenal insufficiency Known hypersensitivity to etomidate Known pregnancy Unaffiliated patient to the social insurance

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: 1<br>ketamine | Drug: Ketamine<br>* Ketamine<br>|
| Active Comparator: 2<br>Etomidate | Drug: Etomidate<br>* Etomidate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal value of the Sepsis-related Organ Failure Assessment (SOFA) |  | at the end of D2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality, length of stay in the intensive care unit and in the hospital, length of stay under artificial ventilation, neurological state at the exit of the hospital and adverse effects : within the first 28 days. |  | at D0 | 
| intubation difficulty |  | at D0 | 
| early complications |  | at D0 | 
| adverse effects |  | at D0 | 
| SOFA in the first 48 hours of hospitalization |  | at the ende of D2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ETOMIDATE, KETAMINE, RAPID SEQUENCE INTUBATION, PREHOSPITAL, During rapid sequence intubation