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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by (Responsible Party): | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00440102 |
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 IV |
| 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 |
| 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
|
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:
Exclusion Criteria:
Presence of contraindication to succinylcholine:
Presence of contraindication to ketamine:
Presence of contraindication to etomidate:
Contacts and Locations
More Information
| 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 |
|
ETOMIDATE KETAMINE RAPID SEQUENCE INTUBATION PREHOSPITAL During rapid sequence intubation |
|
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 |