The effect of ephedrine and phenylephrine on the ED50 of intrathecal bupivacaine required to provide anaesthesia for Caesarean section

ISRCTN	ISRCTN32635781
DOI	https://doi.org/10.1186/ISRCTN32635781
Protocol serial number	N0016176701
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Hammersmith Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gary Stocks
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Added as of 28/07/09: Granted February 2006
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	ephedrine phenylephrine bupivacaine
Primary outcome measure(s)	The ED50 of intrathecal heavy bupivacaine with 25mcg fentanyl required to achieve a block to touch to Xiphisternum in the ephedrine and phenylephrine groups.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	70
Key inclusion criteria	Patients undergoing elective CS with a viable singleton foetus who require regional anaesthesia will be identified.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/02/2006
Date of final enrolment	31/12/2007

Department of Anaesthesia

London
W6 8RF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No