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

September 21, 2011 updated by: Assistance Publique - Hôpitaux de Paris
The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

655

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93000
        • CHU Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ketamine
Drug: Ketamine
Ketamine
Active Comparator: 2
Etomidate
Drug: Etomidate
Etomidate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)
Time Frame: at the end of D2
at the end of D2

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at D0
intubation difficulty
Time Frame: at D0
at D0
early complications
Time Frame: at D0
at D0
adverse effects
Time Frame: at D0
at D0
SOFA in the first 48 hours of hospitalization
Time Frame: at the ende of D2
at the ende of D2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 26, 2007

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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