Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity (KETASED)
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Purpose
The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.
| Condition | Intervention | Phase |
|---|---|---|
|
Intubation; Difficult |
Drug: Ketamine Drug: Etomidate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity |
- Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA) [ Time Frame: at the end of D2 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- intubation difficulty [ Time Frame: at D0 ] [ Designated as safety issue: Yes ]
- early complications [ Time Frame: at D0 ] [ Designated as safety issue: Yes ]
- adverse effects [ Time Frame: at D0 ] [ Designated as safety issue: Yes ]
- SOFA in the first 48 hours of hospitalization [ Time Frame: at the ende of D2 ] [ Designated as safety issue: Yes ]
| Enrollment: | 655 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
ketamine
|
Drug: Ketamine
Ketamine
Other Name: Ketamine
|
|
Active Comparator: 2
Etomidate
|
Drug: Etomidate
Etomidate
Other Name: Etomidate
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations
More Information
Publications:
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00440102 History of Changes |
| Other Study ID Numbers: | P060213 |
| Study First Received: | February 23, 2007 |
| Last Updated: | September 21, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
ETOMIDATE KETAMINE RAPID SEQUENCE INTUBATION PREHOSPITAL During rapid sequence intubation |
Additional relevant MeSH terms:
|
Ketamine Etomidate Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 21, 2013