Condition category
Pregnancy and Childbirth
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/07/2009
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 Gary Stocks

ORCID ID

Contact details

Department of Anaesthesia
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0016176701

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effect of two vasopressors (drugs that are used to prevent blood pressure falling-hypotension- after spinal anaesthesia) on the dosages of local anaesthetic required to provide successful anaesthesia for caesarean section (CS).

As of 28/07/09 this record was updated. All updates can be found under the relevant field with the above update date.

Ethics approval

Added as of 28/07/09:
Granted February 2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Condition

Pregnancy and Childbirth: Anaesthesia

Intervention

Patients were randomised to receive
1. either phenylephrine at a rate of 16.6 µg min^–1 (concentration 1µg ml^–1) or ephedrine at a rate of 1.5 mg min^–1 (concentration 90 µg ml^–1)
2. varying doses of hyperbaric bupivacaine with fentanyl 25 µg using a double-blinded, up-down sequential allocation design

Intervention type

Drug

Phase

Not Specified

Drug names

ephedrine phenylephrine bupivacaine

Primary outcome measures

The ED50 of intrathecal heavy bupivacaine with 25mcg fentanyl required to achieve a block to touch to Xiphisternum in the ephedrine and phenylephrine groups.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective CS with a viable singleton foetus who require regional anaesthesia will be identified.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

70

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/02/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
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

Hospital/treatment centre

Funder name

Hammersmith Hospital NHS Trust (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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19411667

Publication citations

  1. Results

    Hennebry MC, Stocks GM, Belavadi P, Barnes J, Wray S, Columb MO, Lyons G, Effect of i.v. phenylephrine or ephedrine on the ED50 of intrathecal bupivacaine with fentanyl for caesarean section., Br J Anaesth, 2009, 102, 6, 806-811, doi: 10.1093/bja/aep095.

Additional files

Editorial Notes