Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000117718
Ethics application status
Not yet submitted
Date submitted
16/01/2013
Date registered
31/01/2013
Date last updated
3/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Phenylephrine Infusion in Caesarean section under spinal anaesthetic
Scientific title
Randomised double blinded comparator study of timing of Phenylephrine Infusion in elective Caesarean Section under spinal anaesthetic
Secondary ID [1] 281787 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypotension and nausea under spinal anaesthesia 288111 0
Condition category
Condition code
Anaesthesiology 288486 288486 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
timing of commencement of phenylephrine infusion.
Commence infusion at 33mcg/min by syringe driver. Continue till blood pressure maintained, usually 40 minutes
Intervention code [1] 286330 0
Treatment: Drugs
Comparator / control treatment
starting phenylephrine infusion at time of spinal anaesthetic compared with five minutes earlier to minimise hypotension. Control will be usual practice of commencing after spinal has been inserted. These are the two limbs, commencing prior to spinal and commencing after spinal insertion.
Control group
Active

Outcomes
Primary outcome [1] 288644 0
need to treat hypotension BP<100mmHg. Assessed by automated sphygmomanometry
Timepoint [1] 288644 0
up until delivery of child
Secondary outcome [1] 300687 0
need to treat bradycardia. Assessed by ECG
Timepoint [1] 300687 0
till baby is delivered

Eligibility
Key inclusion criteria
Elective caesarean section under spinal anaesthetic
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18yrs. Inability to consent, emergency case

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation to early or routine timing of administration after consent has been obtained. As all are elective patients will be contacted prior to arrival in hospital. Randomisation will be made after consent and prior to commencement by numbered envelopes containing group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number sequencer in SPSS
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Student's t test and Chi Squared

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
13/06/2013
Date of last participant enrolment
Anticipated
3/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 424 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 6185 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 286572 0
Hospital
Name [1] 286572 0
Frankston Hospital
Country [1] 286572 0
Australia
Primary sponsor type
Hospital
Name
Frankston Hospital
Address
Hastings Rd Frankston, Victoria 3199
Country
Australia
Secondary sponsor category [1] 285356 0
None
Name [1] 285356 0
Address [1] 285356 0
Country [1] 285356 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288639 0
Peninsula Health HREC
Ethics committee address [1] 288639 0
Hastings Rd Farnkston, Victoria 3199
Ethics committee country [1] 288639 0
Australia
Date submitted for ethics approval [1] 288639 0
24/02/2013
Approval date [1] 288639 0
Ethics approval number [1] 288639 0

Summary
Brief summary
Comparing haemodynamic stability between commencing phenylephrine infusion five minutes prior to insertion of spinal anaesthetic compared with at time of insertion
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37094 0
A/Prof Terence Edward Loughnan
Address 37094 0
Dept Anaesthesia
Frankston Hospital
Hastings Rd
Frankston
Victoria 3199
Country 37094 0
Australia
Phone 37094 0
+61397847445
Fax 37094 0
Email 37094 0
tloughnan@phcn.vic.gov.au
Contact person for public queries
Name 37095 0
A/Prof Terence Edward Loughnan
Address 37095 0
Dept Anaesthesia
Frankston Hospital
Hastings Rd
Frankston
Victoria 3199
Country 37095 0
Australia
Phone 37095 0
+61397847445
Fax 37095 0
Email 37095 0
tloughnan@phcn.vic.gov.au
Contact person for scientific queries
Name 37096 0
A/Prof Terence Edward Loughnan
Address 37096 0
Dept Anaesthesia
Frankston Hospital
Hastings Rd
Frankston
Victoria 3199
Country 37096 0
Australia
Phone 37096 0
+61397847445
Fax 37096 0
Email 37096 0
tloughnan@phcn.vic.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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