Prevention of post-operative nausea and vomiting (PONV) in 'day surgery patients'; Granisetron v/s Placebo, Cyclizine and Ondansetron.

ISRCTN	ISRCTN07711014
DOI	https://doi.org/10.1186/ISRCTN07711014
Secondary identifying numbers	N0084144579

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

Dr Bhaskar Tandon
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/09/2003
Completion date	01/09/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	It is anticipated to recruit 4 groups of 30 patients each = total of 120 patients into this study.
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2004

Northern Lincolnshire & Goole Hospitals NHS Trust

Grimsby
DN33 2BA
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

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

No information available

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