Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000746932
Ethics application status
Approved
Date submitted
13/07/2011
Date registered
18/07/2011
Date last updated
20/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of sitting up for 5 minutes vs. immediately lying down after spinal anesthesia for cesarean delivery on fluid and ephedrine requirement
Scientific title
Effects of sitting up for 5 minutes vs. immediately lying down after spinal anesthesia for cesarean delivery on fluid and ephedrine requirement
Secondary ID [1] 262622 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-spinal hypotension at cesarean delivery 268318 0
Condition category
Condition code
Anaesthesiology 268449 268449 0 0
Anaesthetics
Reproductive Health and Childbirth 268456 268456 0 0
Childbirth and postnatal care
Surgery 268457 268457 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: sitting up for 5 minutes after spinal anesthesia then lying down to a tilted supine position
Intervention code [1] 266969 0
Prevention
Comparator / control treatment
Control: immediately lying down after spinal anesthesia to a tilted supine position
Control group
Active

Outcomes
Primary outcome [1] 269205 0
Total intraoperative fluid requirement
Timepoint [1] 269205 0
At the end of surgery
Primary outcome [2] 269206 0
Total intraoperative ephedrine requirement
Timepoint [2] 269206 0
At the end of surgery
Secondary outcome [1] 279122 0
Systolic blood pressure will be measured using a standard automated non-invasive blood pressure and heart rate measuring device
Timepoint [1] 279122 0
At baseline and every 2 minutes after spinal anesthesia for a total of 20 minutes
Secondary outcome [2] 279123 0
Heart rate will be measured using a standard automated non-invasive blood pressure and heart rate measuring device
Timepoint [2] 279123 0
At baseline and every 2 minutes after spinal anesthesia for a total of 20 minutes
Secondary outcome [3] 279124 0
Maximum height of sensory block will be assessed clinically by the blinded anesthesiologist using an ice cube
Timepoint [3] 279124 0
Ten minutes after the administration of spinal anesthesia (before the start of surgery)

Eligibility
Key inclusion criteria
- Females
- 18-40 years of age
- Pregnant at term (greater than or equal to 37 weeks gestation)
- Singleton uncomplicated pregnancy
- American Society of Anesthesiologists’ physical class I or II
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- hypertension
- any hypertensive disease of pregnancy
- diabetes mellitus
- any contraindication to regional anesthesia
- allergy to any of the study medications

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)
Research assitant and serially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization schedule with block size of 6
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 3707 0
Saudi Arabia
State/province [1] 3707 0

Funding & Sponsors
Funding source category [1] 267435 0
University
Name [1] 267435 0
Department of Anesthesia and Critical Care, Faculty of Medicine, King Abdulaziz University
Country [1] 267435 0
Saudi Arabia
Primary sponsor type
University
Name
King Abdulaziz University
Address
P.O. Box 80215
Jeddah 21589
Country
Saudi Arabia
Secondary sponsor category [1] 266483 0
None
Name [1] 266483 0
Address [1] 266483 0
Country [1] 266483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269410 0
Research and Ethics Committee
Ethics committee address [1] 269410 0
Ethics committee country [1] 269410 0
Saudi Arabia
Date submitted for ethics approval [1] 269410 0
Approval date [1] 269410 0
01/06/2010
Ethics approval number [1] 269410 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32871 0
Address 32871 0
Country 32871 0
Phone 32871 0
Fax 32871 0
Email 32871 0
Contact person for public queries
Name 16118 0
Prof. Essam E. Abd El-Hakeem
Address 16118 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 16118 0
Saudi Arabia
Phone 16118 0
966-2-6408335
Fax 16118 0
Email 16118 0
[email protected]
Contact person for scientific queries
Name 7046 0
Prof. Essam E. Abd El-Hakeem
Address 7046 0
Department of Anesthesia and Critical Care
King Abdulaziz University Hospital
P.O. Box 80215
Jeddah 21589
Country 7046 0
Saudi Arabia
Phone 7046 0
966-2-6408335
Fax 7046 0
Email 7046 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.