Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity

Intubation; Difficult Clinical Trial

— KETASED  

Official title:

Ketamine Versus Etomidate During Rapid Sequence Intubation: Consequences on Hospital Morbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00440102
• Other study ID #: P060213
• Status: Completed
• Phase: Phase 4
• First received: February 23, 2007
• Last updated: September 21, 2011
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: May 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Drug:
• Ketamine
Ketamine
• Etomidate
Etomidate

Locations

Country	Name	City	State
France	Chu Avicenne	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, — View Citation

Wenzel V, Lindner KH. Best pharmacological practice in prehospital intubation. Lancet. 2009 Jul 25;374(9686):267-8. doi: 10.1016/S0140-6736(09)61071-0. Epub 2009 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)		at the end of D2	Yes
Secondary	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	Yes
Secondary	intubation difficulty		at D0	Yes
Secondary	early complications		at D0	Yes
Secondary	adverse effects		at D0	Yes
Secondary	SOFA in the first 48 hours of hospitalization		at the ende of D2	Yes