Comparison of the effect of Phenylephrine and Ephedrine in treatment of Spinal Anesthesia induced Hypotension in pregnant women candidate for Cesarean section
Determine the effects of Phenylephrine and Ephedrine in the treatment of spinal anesthesia induced Hypotension in pregnant women undergoing Cesarean section
Design
Two groups of parallel, clinical trial, double blinded
Settings and conduct
In this study, 62 patients undergoing elective cesarean section under spinal anesthesia and having hypotension after spinal anesthesia are examined. Patients are randomized to either Phenylephrine or Ephedrine. Patients receive an intravenous intravenous bolus of 100 microgram Phenylephrine or 10 milligram Ephedrine immediately after hypotension after spinal anesthesia. During surgery (during spinal anesthesia, at the outlet of the infant and up to the end of the operation) hemodynamic variables including systolic, diastolic blood pressure and heart rate were measured every 5 minutes. After the removal of the baby, the umbilical cord blood gases were analyzed and Apgar The baby is recorded in minutes 1 and 5. The Apgar score is calculated by the physician, which is not related to the type of drug used
Participants/Inclusion and exclusion criteria
The criteria for healthy pregnant women with uncomplicated singleton class ASA 1 between the ages of 20 to 35 years is higher than 36 weeks' gestation for elective cesarean section under spinal anesthesia.
Exit criteria include: Emergency cesarean section, high risk pregnancies, and any contraindication for spinal anesthesia.
Intervention groups
In this study, pregnant women with Cesarean section under spinal anesthesia were randomly divided into two groups to find the best medicine for improving hypotension due to spinal anesthesia with the least effect on Apgar score and neonatal PH.
Main outcome variables
Find the best medicine to improve blood pressure in pregnant women undergoing cesarean section under spinal anesthesia with minimal effect on the Apgar score and neonatal PH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024909N8
Registration date:2019-06-16, 1398/03/26
Registration timing:registered_while_recruiting
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Faranak Rokhtabnak
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6267
Email address
rolhtabnak.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Phenylephrine and Ephedrine in treatment of Spinal Anesthesia induced Hypotension in pregnant women candidate for Cesarean section
Public title
"Effect of Phenylephrine in treatment of Hypotension"; "Effect of Ephedrine in treatment of Hypotension"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Higher than 36 weeks of gestational age
Elective cesarean section under spinal anesthesia
Pregnant women are healthy and uncomplicated with class ASA 1
Exclusion criteria:
Emergency Caesarean section
High-risk pregnancies
Spinal anesthesia is contraindicated
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, before the patient enters the operating room on the basis of a self-contained envelope, one of the two envelopes in which the type of blood pressure enhancer is written is randomly selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, before entering the patient into the operating room on the basis of an envelope, one of the two envelopes containing the type of blood pressure enhancer was randomly selected and the medicine was given to the treatment staff. It is calculated at the time of the birth of the Apgar's baby by a physician who does not know about the type of prescription drug.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Decreased blood pressure following spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Blood pressure
Timepoint
Mean 3 times the blood pressure measurement before the procedure and then measuring the blood pressure at intervals of 3 minutes after the spinal anesthesia until the birth of the baby, and then every 5 minutes