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

ISRCTN	ISRCTN84471191
DOI	https://doi.org/10.1186/ISRCTN84471191
Secondary identifying numbers	N0128125461

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 31/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philip Barclay
Scientific

Anaesthesia Department
Liverpool Women's Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone	+44 (0)151 708 9988
Email	abc@email.com

Study information

Study design	Prospective randomised double blind controlled pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Antiemetic efficacy of combination Cyclizine-Morphine patient controlled analgesia in postoperative major gynaecological surgery patients
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cyclizine, Morphine
Primary outcome measure	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 study start date	10/11/2003
Completion date	10/04/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Female
Target number of participants	90
Key inclusion criteria	90 subjects will be recruited in total, between 18-65 years old.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	10/11/2003
Date of final enrolment	10/04/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Anaesthesia Department

Liverpool
L8 7SS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

Liverpool Women's Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

31/03/2020: No publications found, all search options exhausted, study status unverified.