Comparing the effect and complications of intravenous Epinephrine and Ephedrine in management of spinal anesthesia hypotension and bradycardia in elective caesarian section
1. Determining the effects and side effects of intravenous epinephrine and ephedrine in the management of hypotension and bradycardia and determining the effects and side effects of intravenous epinephrine and ephedrine on fetal pH and Apgar score due to spinal cesarean section elective cesarean section
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 126 patients, including 63 patients receiving epinephrine and 63 patients receiving ephedrine
Settings and conduct
In the operating room of Kamali Hospital , Intravenous injections of epinephrine or ephedrine measure blood pressure and heart rate every 2 minutes until 20 minutes and then every 5 minutes until 45 minutes.The researcher and patient assessor who analyzed the data both used patient codes
Participants/Inclusion and exclusion criteria
Inclusion criteria :Elective cesarean section candidate, consent to participate in the study, pregnant women 20-40 years old in ASA2 class, gestational age 36-40 weeks ,a drop blood pressure more than 20% or systolic blood pressure less than 100 mm Hg
Exclusion criteria: Contraindications for spinal anesthesia, Primary blood pressure more than 90/140 mm Hg or heart disease , Sensitivity to the drugs used and Diagnosed diseases of the placenta
Intervention groups
Epinephrine injection at a dose of 4 μg bolus in the intervention group or injection of 10 mg intravenous ephedrine at a dose of 10 mg bolus in the control group until the mother reaches systolic blood pressure more than 100 mm Hg
Comparing the effect and complications of intravenous Epinephrine and Ephedrine in management of spinal anesthesia hypotension and bradycardia in elective caesarian section
Public title
Comparison of the effect and side effects of intravenous epinephrine and ephedrine in controlling hypotension and heart rate in cesarean section women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
Pregnant women 40-20 years old in ASA2 class
Gestational age 40-36 weeks
A drop in blood pressure of more than 20% or a decrease in systolic blood pressure of less than 100 mm Hg
Exclusion criteria:
Contraindications for spinal anesthesia
Primary blood pressure more than 90/140 mm Hg or heart disease
Diagnosed diseases of the placenta
Sensitivity to the drugs used
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are entered into the study in an accessible manner and randomly assigned to the intervention and control groups using randomization software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and patient assessor who analyzed the data both used patient codes .Also, the titles of the groups were coded with A and B, but neither of them knew which of the two was the epinephrine group and the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alburz University of Medical Sciences
Street address
kamali hospital , kamali st. , shahid beheshti Ave , city of karaj , alburz
City
karaj
Province
Alborz
Postal code
3134877179
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.ABZUMS.REC.1399.196
Health conditions studied
1
Description of health condition studied
Hypotension and bradycardia following injection of spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of hypotension
Timepoint
Before injecting spinal anesthesia then every 2 minutes to 20 minutes and then every 5 minutes to 45 minutes
Method of measurement
Measurement by monitoring device
2
Description
Bradycardia
Timepoint
Before injecting spinal anesthesia then every 2 minutes to 20 minutes and then every 5 minutes to 45 minutes
Method of measurement
Measurement by monitoring device
Secondary outcomes
1
Description
Apgar fetus
Timepoint
1 minute and 5 minutes after delivery
Method of measurement
Apgar scoring form of 10 points
2
Description
Fetal pH
Timepoint
After delivery and umbilical cord incision
Method of measurement
By sending a cord blood sample to the laboratory and determining the pH of the fetus
Intervention groups
1
Description
Intervention group : Epinephrine is injected at a dose of 4 micrograms bolus until the mother reaches systolic blood pressure of more than 100 mm Hg
Category
Treatment - Other
2
Description
control group :Intravenous ephedrine at a dose of 10 mg as a bolus until the mother reaches systolic blood pressure more than 100 mm Hg