A comparison of two sleep induction drugs used in the intensive care

ISRCTN	ISRCTN39347168
DOI	https://doi.org/10.1186/ISRCTN39347168
Secondary identifying numbers	11-N-94

Submission date: 23/03/2012
Registration date: 30/03/2012
Last edited: 18/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Cornelis Punt
Scientific

Ayrium Medisch Centrum
P.O. box 4446
Heerlen
6401 CX
Netherlands

Email	c.punt@atriummc.nl

Study information

Study design	Prospective open study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Etomidate and S-ketamine for endotracheal intubation in the intensive care: a prospective, open study
Study objectives	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(s)	Medical Ethics Committee of the Atrium Medical Centre (METC) (Medisch Ethische Toetsingscommissie METC - Atrium - Orbis - Zuyd), ref: 11-N-94
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Etomidate, S-ketamine
Primary outcome measure	Mortality within 28 days
Secondary outcome measures	Cortisol levels
Overall study start date	01/04/2008
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	718 patients
Key inclusion criteria	Adult patients admitted in the intensive care department
Key exclusion criteria	1. Younger than 18 years 2. Having received etomidate less than 72 hours before
Date of first enrolment	01/04/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Ayrium Medisch Centrum

Heerlen
6401 CX
Netherlands

Sponsor information

Atrium Medisch Centrum (Netherlands)
Hospital/treatment centre

P.O. Box 4446
Heerlen
6401 CX
Netherlands

Email	c.punt@atriummc.nl
"ROR"	https://ror.org/0367sye10

Funders

Funder type

Hospital/treatment centre

Atrium Medisch Centrum (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan