Contact information
Type
Scientific
Primary contact
Dr Mark Alexander-Williams
ORCID ID
Contact details
Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom
+44 (0)1245 516034
mark.alexander-williams@meht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0355092655
Study information
Scientific title
Acronym
Study hypothesis
To investigate whether cyclizine is more effective than placebo in preventing post operative nausea and vomiting. A secondary aim is to establish whether a combination of cyclizine and dexamethasone is more effective than cyclizine alone.
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
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Nausea and vomiting
Intervention
1. Cyclizine 50mgs per-operatively and rescue ondansatron (control)
2. Dexamethasone 8mgs and cyclizine 50 mgs per-operatively and rescue ondansatron prn (combination)
3. 0.9% saline (placebo).
Randomisation: closed envelope technique. Anaesthetic: Propofol induction, nitrous oxide, isoflurane maintenance, Fentanyl 2 mgs/kg, Diclofenac 75 mgs I.v unless contraindicated. Patient airway maintained as deemed appropriate by the anaesthetist (recorded). Patient paralysed. All patients to receive iv fluids prn per-operatively. Paracetamol and/or codeine for rescue analgesia .
Intervention type
Drug
Phase
Not Specified
Drug names
dexamethasone, cyclizine
Primary outcome measure
Data and demographics recorded - age, time from LMP, smoking Hx, time from starvation, type of surgery, previous postoperative nausea and vomiting (PONV) , previous travel sickness, duration of anaesthesia, reversal used (Y/N), time to first oral intake, time to first mobilisation, time to first food, time to discharge. Vomiting (Y/N) or retching (Y/N) in recovery @ 1, 2, 3 & 4 hours, nausea (none/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hour, pain score (non/mild/moderate/severe) in recovery and @ 1, 2, 3 & 4 hours, rescue anti emetic usage (ondansatron).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
12/02/2001
Overall trial end date
03/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women over the age of 18 undergoing daycase gynaecological laparoscopy.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant exclusion criteria
1. Failure to consent
2. Under 18 years old
Recruitment start date
12/02/2001
Recruitment end date
03/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mid Essex Hospital Services NHS Trust (BH)
Chelmsford
CM1 7ET
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
Funders
Funder type
Government
Funder name
Mid Essex Hospital Services NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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
Basic results (scientific)
Publication list
2004 abstract presented at Anaesthetic Research Society in Liverpool, British Journal of Anaesthesia 93 (4): 618P (2004): http://bja.oxfordjournals.org/cgi/content/citation/93/4/604P