Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity (KETASED)
|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 ]
|Study Start Date:||April 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Active Comparator: 2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00440102
|Bobigny, France, 93000|
|Principal Investigator:||Frederic ADNET, MD, PhD||Assistance Publique - Hôpitaux de Paris|