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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00440102
First received: February 23, 2007
Last updated: September 21, 2011
Last verified: May 2007
  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 4

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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA) [ Time Frame: at the end of D2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440102

Locations
France
Chu Avicenne
Bobigny, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frederic ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ETOMIDATE
KETAMINE
RAPID SEQUENCE INTUBATION
PREHOSPITAL
During rapid sequence intubation

Additional relevant MeSH terms:
Ketamine
Etomidate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 28, 2014