Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
11/04/2014
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 Bhaskar Tandon

ORCID ID

Contact details

Northern Lincolnshire & Goole Hospitals NHS Trust
Diana Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084144579

Study information

Scientific title

Acronym

Study hypothesis

To compare the effectiveness of granisetrone with ondansetrone, cyclizine and placebo in the prevention of post-operative nausea and vomiting in patients undergoing "Day Surgery" under general anaesthesia.

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

Signs and Symptoms: Post operative nausea and vomiting (PONV)

Intervention

Patients are to continue to have general anaesthesia for their surgical procedure. Every participating patient to receive a prophylactic anti emetic, randomly selected, at the beginning of anaesthetic induction.

Anti emetics to be divided into 4 groups:
A: Cyclizine 50mgm I.V.
B: Ondansetrone 4mgm I.V.
C: Granisetrone 1mgm I.V
D: Placebo.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Post operative record of patients PONV status to be recorded by the nurse in PACU (Post anaesthetic care unit). Rescu anti-emetic to be given by the nurse in PACU as per protocol. Emesis score as follows: 0 - None; 1 - Nausea; 2 - Retching; 3 - Vomiting. Patient to complete the simple questionnaire regarding her post operative recovery and return by pre-paid envelope the next day.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

It is anticipated to recruit 4 groups of 30 patients each = total of 120 patients into this study.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2003

Recruitment end date

01/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Lincolnshire & Goole Hospitals NHS Trust
Grimsby
DN33 2BA
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

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