Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/07/2008
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 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 measures

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

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

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

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

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes