Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
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 Philip Barclay

ORCID ID

Contact details

Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 708 9988
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0128125461

Study information

Scientific title

Antiemetic efficacy of combination Cyclizine-Morphine patient controlled analgesia in postoperative major gynaecological surgery patients

Acronym

Study hypothesis

To compare the efficacy of combination morphine plus cyclizine patient controlled analgesia (PCA) versus morphine alone in PCA in patients undergoing major gynaecological surgery following a single prophylactic intravenous dose of cyclizine in theatre. We aim to identify the dose of cyclizine per PCA bolus that is most effective against post-operative nausea and vomiting (PONV) but has minimal side effects.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised double blind controlled pilot 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

Compare the efficacy of combination morphine plus cyclizine patient controlled analgesia (PCA) versus morphine alone in PCA in patients undergoing major gynaecological surgery following a single prophylactic intravenous dose of cyclizine in theatre.

Intervention type

Drug

Phase

Not Specified

Drug names

Cyclizine, Morphine

Primary outcome measures

Assessment of nausea and vomiting, pain scores, morphine requirements, sedation, the need for rescue antiemetic medication, incidence of side effects

Secondary outcome measures

Not provided at time of registration

Overall trial start date

10/11/2003

Overall trial end date

10/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

90 subjects will be recruited in total, between 18-65 years old.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

90

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

10/11/2003

Recruitment end date

10/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthesia Department
Liverpool
L8 7SS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Liverpool Women's Hospital 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

Publication citations

Additional files

Editorial Notes