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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 4

Conditions: Intubation; Difficult

Treatments: Drug: Etomidate; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00440102

P060213

Details and patient eligibility

About

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

Full description

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.

Enrollment: 655 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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655 participants in 2 patient groups

1

Active Comparator group

Description:

ketamine

Treatment:

Drug: Ketamine

2

Active Comparator group

Description:

Etomidate

Treatment:

Drug: Etomidate