This prospective single center clinical trial was designed to compare the hemodynamic effects of low-dose spinal bupivacaine in severely preeclamptic versus healthy parturients undergoing cesarean section. A total of 80 pregnant women with severe preeclamsia and healthy parturients who are candidates for termination of pregnancy with cesarean section are recruited in this study. In both groups of pregnant women, spinal anesthesia is performed with 10 mg hyperbaric %0.5 bupivacaine plus 5 µg sufentanil after receiving 500 ml of IV Ringer's solution. Heart rate and blood pressure were recorded before spinal anesthesia, every 2 minutes for 15 minutes then every 5 minutes until the end of the surgery. Primary outcome is hypotension that is defined as more than 30% decline in mean arterial blood pressure compared to baseline blood pressure in both groups (or systolic blood pressure <100 mmHg in healthy parturients).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101275709N1
Registration date:2011-03-24, 1390/01/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-24, 1390/01/04
Registrant information
Name
Razieh Dastaran
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1262 1353
Email address
dastaran@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Scienece-Research Vice Chancellorship
Expected recruitment start date
2008-04-20, 1387/02/01
Expected recruitment end date
2011-03-05, 1389/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the hemodynamic effects of spinal anesthesia in cesarean section of severely preeclamptic patients and healthy parturients
Public title
Effects of spinal anesthesia in cesarean section of severe preeclamptic patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with severe pre-eclamsia and healthy parturients who are candidate for termination of pregnancy with cesarean section
Exclusion criteria: Presence of coagulopathy (platelet less than 50000); placental abruption; severe fetal distress; history of allergy to local anesthetics; skin infection of injection site and no satisfaction of patients for regional anesthesia
Age
From 14 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan Univercity of Medical Science
Street address
Hamedan Univercity of Medical science-Shahid Fahmideh boulevard-Hamedan
City
Hamedan
Postal code
Approval date
2008-11-22, 1387/09/02
Ethics committee reference number
116450/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Severe preeclampsia
ICD-10 code
014.1
ICD-10 code description
Gestational [pregnancy-induced] hypertension with significant proteinuria
Primary outcomes
1
Description
Blood pressure
Timepoint
Before spinal anesthesia, every 2 minutes for 15 minutes then every 5 minutes until the end of surgery
Method of measurement
According to hydragyr millimeter with hydragyric manometer ALP-K2 model
Secondary outcomes
1
Description
Neonate condition
Timepoint
One and five minute after birth
Method of measurement
APGAR score
Intervention groups
1
Description
Spinal anesthesia was performed with 10 mg hyperbaric %0.5 bupivacaine plus 5 µg sufentanil in two groups after receiving 500 ml of IV Ringer's solution
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Fatemieh Hospital
Full name of responsible person
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Scienece-Research Vice Chancellorship
Full name of responsible person
Dr.Ali Ghaleiha
Street address
Hamedan University of Medical Scienece-Research Vice Chancellorship -Shahid Fahmideh boulevard-Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Scienece-Research Vice Chancellorship
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Razieh Dastaran
Position
Anesthesia resident
Other areas of specialty/work
Street address
Hamedan University of Medical Scienece -Shahid Fahmideh boulevard-Hamedan
City
Hamedan
Postal code
Phone
+98 81 1262 1353
Fax
Email
dastaran@umsha.ac.ir rdastaran@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Scienece
Full name of responsible person
Dr.Razieh Dastaran
Position
Anesthesia resident
Other areas of specialty/work
Street address
Hamedan University of Medical Scienece -Shahid Fahmideh boulevard-Hamedan
City
Hamedan
Postal code
Phone
+98 81 1262 1353
Fax
Email
dastaran@umsha.ac.ir rdastaran@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Razieh dastaran
Position
Anesthesia resident
Other areas of specialty/work
Street address
Hamedan University of Medical Scienece -Shahid Fahmideh boulevard-Hamedan
City
Hamedan
Postal code
Phone
+98 81 1262 1353
Fax
Email
dastaran@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)