Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000472875
Ethics application status
Approved
Date submitted
7/04/2012
Date registered
30/04/2012
Date last updated
1/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sitting position on blood pressure reading among patients for caesarean section under spinal anesthesia
Scientific title
Maximum allowable sitting time following spinal anaesthesia for elective caesarean section and its effect on incidence of hypotension
Secondary ID [1] 280412 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
to define the maximum allowable time of sitting position after spinal anaesthesia for elective caesarean section and its effect on incidence of hypotension. 286244 0
Condition category
Condition code
Anaesthesiology 286459 286459 0 0
Anaesthetics
Reproductive Health and Childbirth 286625 286625 0 0
Normal pregnancy
Surgery 286626 286626 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After approval of ethics committee of King Abdul Aziz university hospital, informed, written consent will be obtained from 90 ASA class I or II patients undergoing elective caesarean section. IV cannula will be established. 500 mL of 6% hydroxyethyl starch 130/0.4 (voluven) will be administered over 20 min. combined epidural- spinal anesthesia will be performed. 10 mg of heavy bupivacaine 0.5% mixed with 20 micro g fentanyl will be injected into the subarachnoid space without any injection via epidural catheter. following that patients were randomly assigned into one of three equal groups of thirty patients each by using sealed envelope method. The randomization was dependent on the time allowed for each patient to be maintained on sitting position after intrathecal injection. In the four groups (group A, B, C and D) the patients were maintained in sitting position for 3, 5, 7 and 9 minutes consequatively before turning them into supine position. 3 min time was considered as a control group.
Intervention code [1] 284639 0
Treatment: Other
Intervention code [2] 284764 0
Prevention
Comparator / control treatment
the 3 min group was considered as a control group and compared to the active groups where patients were kept sitting for 5, 7, & 9 minaccording to the assigned group.
Control group
Active

Outcomes
Primary outcome [1] 286906 0
blood pressure readings was measured using an automatic blood presure monitoring
Timepoint [1] 286906 0
3 months
Primary outcome [2] 286907 0
duration of spinal anesthesia was assessed clinically by using a peice of ice to check for feeling of temperature and dermatomal level and motor blockade by the movement of lower limbs
Timepoint [2] 286907 0
3 months
Secondary outcome [1] 296968 0
dermatomal level was checked for using a peice of ice to check for loss of temperature sensation.
Timepoint [1] 296968 0
3 months
Secondary outcome [2] 296969 0
adverse effect like hypotension, dizziness, nausea & vomiting, inadequate sensory blockade, other
patients were asked for any adverse events beside the measurement of blood pressure on regular bases by using automatic blood pressure monitoring device and checking for dermatomal blockade using temperature assessment using peice of ice
Timepoint [2] 296969 0
3 months
Secondary outcome [3] 296970 0
use of epidural anesthesia as a rescue technique once the level of sensory blockade start to recede (confirmed by using ice cube to check for temperature sensation) and patient starts to complain of pain. local anesthetic agent will be injected via epidural catheter
Timepoint [3] 296970 0
3 months
Secondary outcome [4] 296971 0
effect on fetus by APGAR score assessment
Timepoint [4] 296971 0
3 months

Eligibility
Key inclusion criteria
ASA class I or II patients undergoing elective caesarean section, obtained consent
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
obesity, preexisting hypertension, pregnancy-induced hypertension, known cardiovascular or cerebrovascular disease, abnormal cardiotocography (CTG) tracing, or patients with contraindications to spinal anesthesia

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
14/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 4245 0
Saudi Arabia
State/province [1] 4245 0

Funding & Sponsors
Funding source category [1] 285055 0
Hospital
Name [1] 285055 0
King Abdulaziz University Hospital
Country [1] 285055 0
Saudi Arabia
Primary sponsor type
Hospital
Name
King Abdulaziz University Hospital
Address
P.O. box 80215
King Abdulaziz university hospital
Jeddah 21589
Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 283919 0
None
Name [1] 283919 0
Address [1] 283919 0
Country [1] 283919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287062 0
Unit of Biomedical Ethics Research Committee
Ethics committee address [1] 287062 0
Ethics committee country [1] 287062 0
Saudi Arabia
Date submitted for ethics approval [1] 287062 0
11/09/2011
Approval date [1] 287062 0
06/04/2012
Ethics approval number [1] 287062 0
1/11/0502

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

Contacts
Principal investigator
Name 34033 0
Address 34033 0
Country 34033 0
Phone 34033 0
Fax 34033 0
Email 34033 0
Contact person for public queries
Name 17280 0
Dr Abdullah Kaki
Address 17280 0
P.O. box 2907
Jeddah 21461
Country 17280 0
Saudi Arabia
Phone 17280 0
+966-2-6408335
Fax 17280 0
+966-2-6408335
Email 17280 0
[email protected]
Contact person for scientific queries
Name 8208 0
Dr Abdullah Kaki
Address 8208 0
P.O. box 2907
Jeddah 21461
Country 8208 0
Saudi Arabia
Phone 8208 0
+966-2-6408335
Fax 8208 0
Email 8208 0
+966-2-6408335

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.