Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
06/01/2009
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 Jane Montgomery

ORCID ID

Contact details

Consultant Anaesthetist
Day Surgery Unit
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0)1803 654310

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0224112482

Study information

Scientific title

Acronym

Study hypothesis

Is a combination of prophylatic granisetron and cyclizine more effective in the prevention of post-operative nausea and vomiting than use as single agents in day case gynaecological patients?

Ethics approval

Not provided at time of registration

Study design

Randomised double blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Gynaecological

Intervention

Combination granisetron and cyclizine anti-emetic therapy versus single use granisetron or cyclizine

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To see if the combination anti-emetic regime reduces post-operative nausea and vomiting.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2002

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients over 18 years of age undergoing a day case gynaecological procedure.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Added January 2009: 960

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2002

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Anaesthetist
Torquay
TQ2 7AA
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

South Devon Healthcare NHS Trust (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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17042842

Publication citations

  1. Results

    Johns RA, Hanousek J, Montgomery JE, A comparison of cyclizine and granisetron alone and in combination for the prevention of postoperative nausea and vomiting., Anaesthesia, 2006, 61, 11, 1053-1057, doi: 10.1111/j.1365-2044.2006.04794.x.

Additional files

Editorial Notes