Abstract
Aims: Spinal anesthesia is an accepted technique of anesthesia in elective cesarean sections. However hypotension, resulted from sympathectomy is a common problem especially in pregnant women and prevention of this complication by sysmpathomimetic agents is of potential clinical significance. The aim of this study is to compare the effect of prophylactic infusion of Phenylephrine versus Ephedrine in prevention of hypotension during spinal anesthesia in elective cesarean section.
Design: This study is a randomized double- blind clinical trial which is performed on 90 patients in Tabriz Alzahra obstetric hospital during approximately 17 months.
Methods: Ninety patients are enrolled in this study and are divided randomly to three groups to receive intervention drugs or placebo. After completion of infusions, all patients were received spinal anesthesia, in sitting position from L4-L5 or L3-L4 inter vertebral spaces with 2.5cc of Bupivacaine 0.5%(12.5mg) and 2.5 μg sufentanil.
Participants' of the study are healthy pregnant women with gestational age of 36 weeks or higher who are candidate for elective cesarean section under spinal anesthesia. Patients with <36 weeks of gestation , emergency cesarean section, high risk, any contraindication of spinal anesthesia and unexpected events during surgery are excluded from study.
Interventions: Ninety patients are enrolled in this study and are divided randomly to three groups. Group Ph received phenylephrine infusion, group E received ephedrine infusion while group P were delivered placebo.
Basic variables of outcome: perioperative maternal vital signs (Blood pressure, heart rate and arterial oxygen saturation) and Maternal perioperative complications and also neonatal outcome including 1st and 5th apgar scores and arterial blood gas analyses are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012120911700N1
Registration date:2013-07-21, 1392/04/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-21, 1392/04/30
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prophylactic infusion of phenylephrine with ephedrine for prevention of hypotension in elective cesarean section under spinal Anesthesia
Public title
Prophylactic effect of phenylephrine on post-spinal hypotension during cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: any healthy pregnant women with gestational age of 36 weeks or higher and non emergency cesarean section. Exclusion criteria: gestational age less than 36 weeks; emergency cesarean section; any contraindication of spinal anesthesia (patient refusal , coagulopathy , hemorrhage or hypovolemic shock) and unexpected events during surgery such a hemorrhage or sensory block level blow or higher then T4-T5 after spinal anesthesia.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Women's Reproductive Health Research Center,Tabriz University of Medical Sciences, Tabriz, Iran
Street address
Tabriz Univercity of Medical Sciences, Daneshgah ave, Tabriz
City
Tabriz
Postal code
Approval date
2008-11-24, 1387/09/04
Ethics committee reference number
5/4/3036
Health conditions studied
1
Description of health condition studied
Spinal Anesthesia, Hypotention
ICD-10 code
O89.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during the puerperium
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minute until fetal delivery,then every 5 minute throughout surgery
Method of measurement
Noninvasive blood pressure control with noninvasive mamometer
2
Description
Maternal complications(Dysrhythmias,nausea and vomiting,other complications) ting,other complications
Timepoint
Continuous Inspection
Method of measurement
Electrocardiogram, continuous Inspection
Secondary outcomes
1
Description
Neonatal outcome
Timepoint
1st and 5th minutes Apgar Scores after neonatal delivery
Method of measurement
1st and 5th minutes Apgar Scoring system
Intervention groups
1
Description
Intervention group1: Infusion of 450 micrograms Phenylephrine in 250 milliliters of normal saline during 30 minutes before performing spinal anesthesia
Category
Treatment - Drugs
2
Description
Intervention group 2: Infusion of 45 milligrams Ephedrine in 250 milliliters of normal saline during 30 minutes before performing spinal anesthesia
Category
Treatment - Drugs
3
Description
Control group::Infusion of 250 milliliters of normal saline during 30 minutes before performing spinal anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra academic hospital
Full name of responsible person
Farnaz Moslemi Tabrizi
Street address
South Artesh Ave.Alzahra academic hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sceince
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Golgasht ave, Daneshgah square, Tabriz
City
Tabriz
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, Tabriz University of Medical Sceince
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
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi Tabrizi
Position
Anesthesiologist,Associated professor of Anesthesia
Other areas of specialty/work
Street address
South Artesh Ave.Alzahra Academic Hospital
City
Tabriz
Postal code
Phone
+98 41 1329 6295
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi Tabrizi
Position
Anesthesiologost,associated Professor of anesthesia
Other areas of specialty/work
Street address
South Artesh Ave,Alzahra hospital,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1329 6295
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi Tabrizi
Position
Anesthesiologist,Associated Professor of Anesthesia
Other areas of specialty/work
Street address
Alzahra hospital,South Artesh Ave,Tabriz
City
Tabriz
Postal code
Phone
+98 41 1329 6295
Fax
Email
moslemifa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)