Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity
Brief Summary
The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.
Condition or Disease
- Intubation; Difficult
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years and older (Adult, Older Adult) |
Enrollment: | 655 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingSINGLE:
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Clinical Trial Dates
Start date: | Apr 01, 2007 | |
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Primary Completion: | Mar 01, 2008 | ACTUAL |
Completion Date: | Mar 01, 2008 | ACTUAL |
Study First Posted: | Feb 26, 2007 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Sep 21, 2011 |
Sponsors / Collaborators
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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.
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.
Participant Groups
-
ketamine
-
Etomidate
Eligibility Criteria
Sex: | All |
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Minimum Age: | 18 |
Age Groups: | Adult / Older Adult |
Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA) at the end of D2
Secondary Outcomes
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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. at D0
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intubation difficulty at D0
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early complications at D0
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adverse effects at D0
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SOFA in the first 48 hours of hospitalization at the ende of D2
More Details
NCT Number: | NCT00440102 |
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Acronym: | KETASED |
Other IDs: | P060213 |
Study URL: | https://clinicaltrials.gov/study/NCT00440102 |
Last updated: Sep 29, 2023