Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/11/2014
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 A Ananthakrishnan

ORCID ID

Contact details

Anaesthetics
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
+44 (0)1482 328541

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084125057

Study information

Scientific title

Acronym

Study hypothesis

To compare the effect of two fasting regimens on the incidence of postoperative nausea and vomiting (PONV) after elective lower segment caesarean sections (LSCS) under spinal anaesthesia.

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

Prevention

Patient information sheet

Condition

Signs and Symptoms: Post-operative nausea and vomiting (PONV)

Intervention

Patients undergoing elective caesarean section will be randomly assigned to either of the following two groups:

Group A: Fasted overnight from 12 midnight
Group B: A light breakfast of two slices of toasts and a cup of tea/coffee will be allowed 4 hours preoperatively

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/08/2001

Overall trial end date

01/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40 patients in each group, 80 patients in total

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/08/2001

Recruitment end date

01/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Anaesthetics
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes