Condition category
Not Applicable
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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 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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes