The aim of study is evaluating the prophylactic effect of phenylepherine and ephedrine in hemodynamic state of elective cesarean cases during spinal anesthesia. 100 pregnant women with age 18-35 years was studied.After stablishing vital sign and spinal anesthesia with 12mg Bupivacaine 0.5%, slow injection of a prophylactic dose of 100 microgram phenylephrine or 10 mg ephedrine was administered intravenously to patients randomly. Blood pressure and heart rates, nausea & vomiting in mothers and infants apgar score in 1 and 5 minutes of schedule in the chart of each patient was recorded.Arterial blood samples were taken from the infant's umbilical cord.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208136148N2
Registration date:2013-01-25, 1391/11/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-25, 1391/11/06
Registrant information
Name
Hakimeh Alreza Amiri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
halereza@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2012-05-30, 1391/03/10
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Phenylephrine & Ephedrine on maternal hemodynamic changes and umbilical cord arterial blood gases in spinal anesthesia
Public title
The effects of Phenylepherine and Ephedirne on maternal blood pressure and heart rate variation and umbilical cord arterial blood gases in spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:18 to 35 years pregnant women candided for cesarean secton with ASA class I,II
Exclusion criteria: Hypertension BP>140/90; DM; Cardiovascular and cerbrovascular disease; Significant fetal abnormalities; contraindication of spinal anesthesia; mothers who are at the start of active phase of labor
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Daneshgah Squre, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2012-05-26, 1391/03/06
Ethics committee reference number
6432/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Cesarean Section
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline BP before Spinal anesthesia and every 2 minutes control until the end of surgery
Method of measurement
Non invasive BP Cuff
2
Description
Heart rate
Timepoint
Before spinal anesthesia until the end of surgery every 2 minutes
Method of measurement
ECG
Secondary outcomes
1
Description
Lactate of umbilical artery
Timepoint
Immediatly after birth
Method of measurement
ABG
2
Description
Infant Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar Score
3
Description
Nausea & Vomiting
Timepoint
During spinal anesthesia
Method of measurement
Observation
4
Description
PH of umbilical artery
Timepoint
Immediatly after birth
Method of measurement
ABG
5
Description
Base excess
Timepoint
Immediatly after birth
Method of measurement
ABG
Intervention groups
1
Description
100 microgram phenylepherine IV injection in one minute after spinal anesthesia to first group
Category
Prevention
2
Description
10mg ephedrine IV prophylactic injection in one minute after spinal anesthesia to second group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
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
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza Amiri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ayatollah Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com , ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza Amiri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ayatollah Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
halereza@yahoo.com , ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr Hakimeh Alereza Amiri
Position
Assistant Professor Of Anesthesiology
Other areas of specialty/work
Street address
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)