Aim: comparing the effect of Phenylephrine and ephedrine in the treatment of hypotension caused by nerve block in the spinal anesthesia in patient undergoing cesarean section in Dezyany educational and medical center, Gorgan, Iran, 2012. It is a double-blind, clinical trial with inclusion criteria: patients older than 18 yr., ASA (American Society of Anesthesiologists) I and II and exclusion criteria: women with pre-existing or pregnancy-induced hypertension. 104 patients who were undergoing cesarean section were randomized into two groups: Group P (100µg Phenylephrine) and Group E (6µg Ephedrine). We compared the hemodynamic parameters (blood pressure, heart rate) and the incidence of hypotension between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072910340N4
Registration date:2012-08-15, 1391/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-15, 1391/05/25
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan university of medical sciences
Expected recruitment start date
2011-07-14, 1390/04/23
Expected recruitment end date
2012-04-22, 1391/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Phenylephrine and Ephedrine in treatment of Hypotension during Spinal Anesthesia for Cesarean Section
Public title
Comparison of phenylephrine and ephedrine for Hypotension treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients older than 18 yr.; ASA (American Society of Anesthesiologists) I and II; weight of 50–120 kg; height of 150–180 cm; women with singleton pregnancies scheduled for elective caesarean delivery under spinal anesthesia. Exclusion criteria: Women with pre-existing or pregnancy-induced hypertension, diabetes mellitus, known cardiovascular or cerebrovascular disease, fetal abnormality, or contraindication to spinal anesthesia.
Age
From 15 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golstan university of medical sciences
Street address
Golestan university of medical sciences
City
Gorgan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90010025157
Health conditions studied
1
Description of health condition studied
hypotension
ICD-10 code
E00-E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
hypotension
Timepoint
during surgery
Method of measurement
monitoring
Secondary outcomes
1
Description
nausea and vomoting
Timepoint
after general anesthesia in recovery
Method of measurement
ask from patient
Intervention groups
1
Description
Group E received a 1-mL bolus of ephedrine 6 mg/mL
Category
Treatment - Drugs
2
Description
Group P received a 1-mL bolus of phenylephrine 100 µg/mL
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dezyani hospital
Full name of responsible person
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of medical sciences
Full name of responsible person
Dr. Mohammad Vakili (Director of Research and Technology)
Street address
Vice chancellor for Research, Golestan University of Medical Sciences, kilometer 2 of Sari road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
5th of Azar hospital
Full name of responsible person
Kazem Kazem nejad
Position
anesthesiologist
Other areas of specialty/work
Street address
5th of Aar hospital, Kkh squre, 5 Azar street
City
Gorgan
Postal code
Phone
+98 17 1442 1651
Fax
Email
kazemnejad1341@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Mohammad Aryaie
Position
master
Other areas of specialty/work
Street address
5th of Azar hospital
City
Gorgan
Postal code
Phone
+98 17 1442 1651
Fax
Email
aryaie2009@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan university of medical sciences
Full name of responsible person
Amin hasanzad
Position
bachelor degree
Other areas of specialty/work
Street address
5th Azar hospital
City
Gorgan
Postal code
Phone
Fax
Email
hassanzad_amin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)