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 |
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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
Scientific
Department of Anaesthesia
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2 JZ
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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) |
Study objectives | 1. 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) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Remifentanil, etomidate, propofol |
Primary outcome measure | The end points are: 1. Intubating conditions 2. Cardiovascular stability |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/08/2002 |
Completion date | 01/06/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 40 |
Key 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. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/08/2002 |
Date of final enrolment | 01/06/2004 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Hull Royal Infirmary
Hull
HU3 2 JZ
United Kingdom
HU3 2 JZ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
The North and South Bank Research and Development Consortium (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |