A randomised double-blind prospective study to compare the intubating conditions with remifentanil (4 ug/mkg) and either propofol (2 mg/kg) or etomidate (0.3 mg/kg)

ISRCTN ISRCTN84400696
DOI https://doi.org/10.1186/ISRCTN84400696
Secondary identifying numbers N0084113942
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
11/12/2014
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

Not provided at time of registration

Contact information

Dr Ian McNeil
Scientific

Department of Anaesthesia
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2 JZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised double-blind prospective study to compare the intubating conditions with remifentanil (4 ug/mkg) and either propofol (2 mg/kg) or etomidate (0.3 mg/kg)
Study objectives1. To investigate whether there is a role for etomidate for intubation without muscle relaxants?
2. Is it more stable than propofol?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Intubation
Intervention1. Remifentanil and etomidate
2. Remifentanil and propofol

Both the patients and the intubating anaesthetist will be blinded to the induction agents administered by a second anaesthetist.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Remifentanil, etomidate, propofol
Primary outcome measureThe end points are:
1. Intubating conditions
2. Cardiovascular stability
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2002
Completion date01/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants40
Key inclusion criteria40 American Society of Anesthesiologists (ASA) 1 and 2 non-obese (Body Mass Index [BMI] <30) elective surgical patients aged between 18 and 65 years. They must require intubation for their proposed surgery.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2002
Date of final enrolment01/06/2004

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

Hull Royal Infirmary
Hull
HU3 2 JZ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

The North and South Bank Research and Development Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan