Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian McNeil

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes