Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intubation; Difficult
Intervention: Ketamine (Drug); Etomidate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s): Frederic ADNET, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Summary
The expected benefit is a reduction of the morbidity of patients admitted in the intensive
care unit having received ketamine for intubation.
Clinical Details
Official title: Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Primary outcome: Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)
Secondary outcome: 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.intubation difficulty early complications adverse effects SOFA in the first 48 hours of hospitalization
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Chu Avicenne, Bobigny 93000, France
Additional Information
Starting date: April 2007
Last updated: September 21, 2011
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