Condition category
Surgery
Date applied
23/03/2012
Date assigned
30/03/2012
Last edited
18/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Endotracheal intubation is a medical procedure in which a tube is placed into the windpipe (trachea), through the mouth or the nose. It is a routine emergency procedure in intensive care. For this procedure it is usual to make the patient asleep, and for this purpose several drugs are available. Several drugs have adverse effects on blood pressure. However, blood pressure remains stable after the use of etomidate, therefore etomidate is a preferable drug for sick and unstable patients. However, it has been suggested that a single dose of etomidate can be detrimental for the patient, resulting in higher mortality (death rate). The aim of this study was to compare the safety of etomidate with another drug, S-ketamine, well known for its blood pressure stability.

Who can participate?
Adult patients in the intensive care department who needed endotracheal intubation in order to start mechanical ventilation.

What does the study involve?
Participants underwent endotracheal intubation, with each patient receiving either etomidate or S-ketamine. The consequences of the two drugs were compared in terms of mortality within 28 days and blood cortisol levels.

What are the possible benefits and risks of participating?
A disadvantage of S-ketamine are the nasty dreams, which can occur in some patients. To avoid these dreams, S-ketamine was combined with a small dose of midazolam.

Where is the study run from?
Atrium Medisch Centrum (Netherlands).

When is the study starting and how long is it expected to run for?
The study started in April 2008 and lasted until December 2009.

Who is funding the study?
Atrium Medisch Centrum (Netherlands).

Who is the main contact?
Dr Cornelis Punt
c.punt@atriummc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cornelis Punt

ORCID ID

Contact details

Ayrium Medisch Centrum
P.O. box 4446
Heerlen
6401 CX
Netherlands
c.punt@atriummc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11-N-94

Study information

Scientific title

Etomidate and S-ketamine for endotracheal intubation in the intensive care: a prospective, open study

Acronym

Study hypothesis

The safety of and the mortality after a single dose of etomidate and S-ketamine, used in the intensive care unit, are equal.

Ethics approval

Medical Ethics Committee of the Atrium Medical Centre (METC) (Medisch Ethische Toetsingscommissie METC - Atrium - Orbis - Zuyd), ref: 11-N-94

Study design

Prospective open study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Endotracheal intubation

Intervention

Routine procedure, endotracheal intubation.

Each patient received one of the following drugs:
1. Etomidate 0.2 - 0.3 mg/kg
2. S-Ketamine 0.5 mg/kg
These drugs were used to make the patients sleep before endotracheal intubation, which is an emergency procedure in the intensive care.

Intervention type

Drug

Phase

Not Applicable

Drug names

Etomidate, S-ketamine

Primary outcome measures

Mortality within 28 days

Secondary outcome measures

Cortisol levels

Overall trial start date

01/04/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients admitted in the intensive care department

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

718 patients

Participant exclusion criteria

1. Younger than 18 years
2. Having received etomidate less than 72 hours before

Recruitment start date

01/04/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Ayrium Medisch Centrum
Heerlen
6401 CX
Netherlands

Sponsor information

Organisation

Atrium Medisch Centrum (Netherlands)

Sponsor details

P.O. Box 4446
Heerlen
6401 CX
Netherlands
c.punt@atriummc.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Atrium Medisch Centrum (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes