The aim of this study: Evaluation of the effect of pseudo ephedrine in prevention of decrease of blood pressure due to spinal anesthesia during elective cesarean section. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A and B groups. The study is double blind, single-center, phase 3 trial. Inclusion criteria: Pregnant women candidates for spinal anesthesia cesarean section. Exclusion criteria: Systolic blood pressure more 120 mm Hg or lower than 60 mm Hg; diabetes; thyroid disease; beta agonist and beta blocker use; preeclampsia; eclampsia; preterm labor. Sample size: 60 patients are participated in the study with 30 patients in each group. Intervention group: pseudo ephedrine syrup 60 mg. Primary outcome: decrease of blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042733664N1
Registration date:2017-08-12, 1396/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-12, 1396/05/21
Registrant information
Name
Aylar Havazyari
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 0611
Email address
a.havazyari@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of pseudo ephedrine in prevention of decrease of blood pressure due to spinal anesthesia during elective cesarean section
Public title
The effect of pseudo ephedrine in prevention of decrease of blood pressure due to spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women candidates for spinal anesthesia cesarean section
Exclusion criteria: Systolic blood pressure more 120 mm Hg or lower than 60 mm Hg; diabetes; thyroid disease; beta agonist and beta blocker use; preeclampsia; eclampsia; preterm labor
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.5
Health conditions studied
1
Description of health condition studied
spinal anaesthesia
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during labour and delivery
Primary outcomes
1
Description
Blood pressure
Timepoint
Before intervention and every 5 minute after intervention until 40 minute
Method of measurement
Mercury milimeter with mercurous gauge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Single dose of 60 mg pseudoephedrine syrup before spinal anaesthesia
Category
Treatment - Drugs
2
Description
Control group: No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahrood
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Aylar Havazyari
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahrood
Postal code
4318936199
Phone
+98 233220611
Fax
Email
draylarhavazyari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahrood
Postal code
4318936199
Phone
+98 912 373 4372
Fax
Email
dr.yousefkoloukhianesthezia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Aylar Havazyari
Position
Medical student
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahroud
Postal code
4318936199
Phone
+98 23 3222 0611
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)