Comparison of the effect of norepinephrine and phenylephrine on maternal hemodynamic changes after spinal anesthesia in cesarean section
Design
The clinical trial was randomized with parallel, single-blind, phase three, groups in which 52 patients were randomly assigned to two groups of 26 patients with a size of 4 blocks.
Settings and conduct
Pregnant women aged 18-35 years are candidates for elective cesarean delivery referred to Ayatollah Rouhani Educational and Medical Center of the study community. Patients will be randomly divided into intervention group 1: after spinal anesthesia injection of prophylaxis bolus 10 micrograms norepinephrine and group 2 intervention: after spinal anesthesia injection of prophylaxis bolus 100 micrograms phenylephrine. Syringes containing norepinephrine and phenylephrine Put one shape, one size and correct inside the cans and then write a 3-digit code on each can. After the patient enters the study, one of these cans is assigned to the patient and the code is written on the can on the patient's file (study checklist). Unlock the codes will be done after the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:18 to 35 years pregnant women, Elective cesarean Section, American Society of Anesthesiologists Classification (ASA) I,II
Inclusion Criteria: ASA Class>3, Bradycardia, Hypertension, Use of anti hypertensive drugs, Operation longer than 3 hours
Intervention groups
Intervention group 1: After spinal anesthesia, prophylaxis injection of 10 micrograms of norepinephrine
Intervention group 2: After spinal anesthesia, prophylaxis injection of 100 micrograms phenylephrine
Main outcome variables
Blood pressure, Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101213005381N15
Registration date:2022-05-29, 1401/03/08
Registration timing:prospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of norepinephrine and phenylephrine on maternal hemodynamic changes after spinal anesthesia in cesarean section
Public title
The effect of norepinephrine and phenylephrine on maternal hemodynamic changes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 35 years pregnant women
Elective cesarean delivery
American Society of Anesthesiologists Classification (ASA) 1 &2
Exclusion criteria:
American Society of Anesthesiologists Classification (ASA) > 3
Bradycardia
Hypertension
Use of anti hypertensive drugs
Operation longer than 3 hours
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using block blocks of block size 4. Thus, 4 blocks consist of random combinations of compounds 2 to A (phenylephrine) and 2 to B (norepinephrine). Random sequencing of blocks will be done by a statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blindness of the study is that patients are unaware of the medication regimen, but the anesthesiologist, the patient evaluator (anesthesia assistant) is aware of the regimen.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Siences
Street address
Babol University of Medical Sciences, Gangafrooz Street, Daneshgah Square,
City
Babol
Province
Mazandaran
Postal code
471764136
Approval date
2022-04-25, 1401/02/05
Ethics committee reference number
IR.MUBABOL.REC.1401.026
Health conditions studied
1
Description of health condition studied
Cesarean Section
ICD-10 code
O74
ICD-10 code description
Complications of anesthesia during labor and delivery
Primary outcomes
1
Description
Percentage of people with hypertension
Timepoint
Before spinal anesthesia once and then after spinal anesthesia once every 3 minutes until the baby leaves and then twice 10 minutes after delivery.
Method of measurement
Monitoring of blood pressure, mm Hg
2
Description
Number of Heart rate
Timepoint
Before spinal anesthesia once and then after spinal anesthesia once every 3 minutes until the baby leaves and then twice 10 minutes after delivery.
Method of measurement
Number per minute using pulse oximeter (Sazgan Gostar Company)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After spinal anesthesia, prophylaxis injection of 10 micrograms of norepinephrine Intervention group
Category
Prevention
2
Description
Intervention group: After spinal anesthesia, prophylaxis injection of 100 micrograms phenylephrine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Nadia Banihashem
Street address
Ganjafrooz Avenue, Daneshgah Square, Ruhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3233 8301
Email
n.banihashem@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?