Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity (KETASED)
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|ClinicalTrials.gov Identifier: NCT00440102|
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : September 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Intubation; Difficult||Drug: Ketamine Drug: Etomidate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||655 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
Active Comparator: 1
Active Comparator: 2
- Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA) [ Time Frame: at the end of D2 ]
- 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 ]
- intubation difficulty [ Time Frame: at D0 ]
- early complications [ Time Frame: at D0 ]
- adverse effects [ Time Frame: at D0 ]
- SOFA in the first 48 hours of hospitalization [ Time Frame: at the ende of D2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440102
|Bobigny, France, 93000|
|Principal Investigator:||Frederic ADNET, MD, PhD||Assistance Publique - Hôpitaux de Paris|