A study to establish the efficacy of dexamethasone used in combination with cyclizine in the prevention of post operative nausea and vomiting

ISRCTN ISRCTN18556628
DOI https://doi.org/10.1186/ISRCTN18556628
Secondary identifying numbers N0355092655
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
10/07/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mark Alexander-Williams
Scientific

Mid Essex Hospital Services NHS Trust (BH)
Broomfield Hospital
Chelmsford
CM1 7ET
United Kingdom

Phone +44 (0)1245 516034
Email mark.alexander-williams@meht.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Nausea and vomiting
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)dexamethasone, cyclizine
Primary outcome measureData 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 measuresNot provided at time of registration
Overall study start date12/02/2001
Completion date03/12/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants150
Key inclusion criteriaWomen over the age of 18 undergoing daycase gynaecological laparoscopy.
Key exclusion criteria1. Failure to consent
2. Under 18 years old
Date of first enrolment12/02/2001
Date of final enrolment03/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Mid Essex Hospital Services NHS Trust (BH)
Chelmsford
CM1 7ET
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Mid Essex Hospital Services NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results abstract presented at Anaesthetic Research Society in Liverpool, British Journal of Anaesthesia 93 (4): 618P (): 01/10/2004 No No