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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00440102
Acronym
KETASED
Enrollment
655
Registered
2007-02-26
Start date
2007-04-30
Completion date
2008-03-31
Last updated
2011-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult

Keywords

ETOMIDATE, KETAMINE, RAPID SEQUENCE INTUBATION, PREHOSPITAL, During rapid sequence intubation

Brief summary

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

Detailed 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.

Interventions

DRUGEtomidate

Etomidate

DRUGKetamine

Ketamine

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximal value of the Sepsis-related Organ Failure Assessment (SOFA)at the end of D2

Secondary

MeasureTime 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 difficultyat D0
early complicationsat D0
adverse effectsat D0
SOFA in the first 48 hours of hospitalizationat the ende of D2

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026