Comparison of norepinephrine with phenylephrine in the prevention and treatment of hypotension in cesarean section undergoing spinal anesthesia
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 3 on 40 patients.
Settings and conduct
In this randomized double-blind clinical trial performed on 40 pregnant women undergoing spinal anesthesia in Mahzad hospital in Urmia, patients in two groups of 20 will randomly receive 5 micrograms of phenylephrine or 5 micrograms of norepinephrine. Patients and statistical analyzers will be unaware of group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study, age between 20 to 45 years, lack of sensitivity to phenylephrine and norepinephrine - Exclusion criteria: having liver, kidney and heart diseases- sensitivity to anesthetics
Comparison of norepinephrine with phenylephrine in the prevention and treatment of hypotension in cesarean section undergoing spinal anesthesia
Public title
Effect of norepinephrine with phenylephrine in the prevention of hypotension undergoing spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Age between 20 to 45 years
Lack of sensitivity to norepinephrine and phenylephrine
Exclusion criteria:
Having liver, kidney and heart disease
Sensitivity to anesthetics
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 10 blocks (Totally 40 patients). Then, within each block, subjects will be randomly assigned to norepinephrine or phenylephrine group . Random assignment will be done using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of their allocation into the intervention groups and the statistical analyzer received the data as codes, not the actual grouping.
Patients remain unaware of being in intervention groups because after spinal anesthesia patients are prescribed sedatives and drugs are administered intra serum and the patient is unable to distinguish the type of drug because both are stored in brown glass. The statistical analyzer also received the data in codes A and B, not the norepinephrine and phenylephrine groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.UMSU.REC.1400.376
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95
ICD-10 code description
Hypotension
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before intervention, 5, 10, 15, 20, 25 and 30 minutes after intervention
Method of measurement
Blood pressure monitor
2
Description
Diastolic blood pressure
Timepoint
Before intervention, 5, 10, 15, 20, 25 and 30 minutes after intervention
Method of measurement
Blood pressure monitor
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
It is recorded up to 30 minutes after the intervention if observed
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company)is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 50 micrograms of phenylephrine (Produced by Caspian company) will be injected intravenously.
Category
Treatment - Drugs
2
Description
Intervention group 2: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company) is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 5 micrograms of norepinephrine(Produced by Caspian company) will be injected intravenously .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahzad Women’s Medical Center
Full name of responsible person
Dr. Hadi Hooshyar
Street address
Mahzad Women’s Medical Center; Hasani street, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 0998
Email
hooshyar.h@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 1930
Email
mohebbi.i@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?