Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084113942
Study information
Scientific title
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)
Acronym
Study hypothesis
1. To investigate whether there is a role for etomidate for intubation without muscle relaxants?
2. Is it more stable than propofol?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Intubation
Intervention
1. 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 type
Drug
Phase
Not Applicable
Drug names
Remifentanil, etomidate, propofol
Primary outcome measures
The end points are:
1. Intubating conditions
2. Cardiovascular stability
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
01/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
40 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2002
Recruitment end date
01/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull Royal Infirmary
Hull
HU3 2 JZ
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The North and South Bank Research and Development Consortium (UK)
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