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
Protocol serial number	N0084144579
Sponsor	Department of Health
Funder	Northern Lincolnshire and Goole Hospitals NHS Trust (UK), NHS R&D Support Funding

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	120
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

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan