Contact information
Type
Scientific
Primary contact
Dr Rachel Elliott
ORCID ID
Contact details
Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 553732
c.glazener@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/15/05
Study information
Scientific title
Acronym
Study hypothesis
Literature review, national survey and randomised controlled trial. This study uses a prospective randomised controlled trial design, to assess the relative cost effectiveness of inhalational and total intravenous anaesthesia, in day case surgery for adult and paediatric patients requiring general anaesthesia.
The objectives are to:
1. Assess the relative clinical outcomes of principle anaesthetic methods used in adult and paediatric day surgery
2. Identify the resource use and associated costs incurred by the NHS during the anaesthetic and post anaesthetic period for principle anaesthetic methods
3. Determine patient acceptability of principal anaesthetic methods used
4. Use clinical, economic and humanistic data collected in this study to assess the relative cost effectiveness of principle anaesthetic methods used.
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Not applicable
Intervention
The adult study has four arms (propofol then propofol; propofol then isoflurane/N2O propofol then sevoflurane then sevoflurane/N2O), 330 patients in each arm. The paediatric study has two arms (thiopentone [ages 3 to 6] or propofol [ages 7 to 10] then halothane/N2O; sevoflurane then hevoflurane/N2O [ages 3 to 10]), 220 patients in each arm.
Intervention type
Drug
Phase
Not Specified
Drug names
propofol, isoflurane, sevoflurane, thiopentone, halothane
Primary outcome measures
Postoperative nausea and vomiting (PONV)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/1999
Overall trial end date
31/07/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Adult general, orthopaedic and gynaecology patients, and paediatric general and ear, nose and throat (ENT) patients.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
1,760
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/1999
Recruitment end date
31/07/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Services Research Unit
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/12709296
Publication citations
-
HTA monograph
Elliott RA, Payne K, Moore JK, Davies LM, Harper NJ, St Leger AS, Moore EW, Thoms GM, Pollard BJ, McHugh GA, Bennett J, Lawrence G, Kerr J, Which anaesthetic agents are cost-effective in day surgery? Literature review, national survey of practice and randomised controlled trial., Health Technol Assess, 2002, 6, 30, 1-264.