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Completed

NCT Number: NCT00440102

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chu Avicenne

Bobigny, 93000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ketamine

Drug

Ketamine

Etomidate

Drug

Etomidate

Primary outcomes

  1. Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)

    Time frame: at the end of D2

Secondary outcomes

  1. 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.

    Time frame: at D0

  2. intubation difficulty

    Time frame: at D0

  3. early complications

    Time frame: at D0

  4. adverse effects

    Time frame: at D0

  5. SOFA in the first 48 hours of hospitalization

    Time frame: at the ende of D2

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: KETASED

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2007
Registry last updated
Sep 22, 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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