Comparison of the effect of Norepinephrin and Ephedrine in the treatment of hypotension due to spinal anesthesia in cesarean section on fetal umbilical cord pH - A double-blinded randomized controlled trial
Comparison of the effect of norepinephrine and ephedrine in the treatment of hypotension induced by spinal anesthesia in cesarean section on fetal umbilical cord artery pH and lactate
Design
This study will be conducted as a double-blind randomized phase 3 clinical trial in two groups with 48 participants who are treated with Ephedrine or Norepinephrine. Randomization will be done by Randomization Allocation Software.
Settings and conduct
This study will be conducted in Akbarabadi Hospital in 1401. Patients will be blinded to type of injected medicine. Only the anesthesiologist will be aware of patient allocation and will control the condition of the patients during anesthesia. Outcomes will be collected in checklists by one of the researchers who is not aware of the patients' allocation.
Participants/Inclusion and exclusion criteria
The inclusion criteria is pregnant women between 36 to 40 weeks of gestational age with singleton pregnancy who are chosen for elective cesarean section. Pregnant women between 20 and 35 years old will be selected for study. Patients with history of hypertension (>140/90), cardiovascular or cerebrovascular diseases, complications of pregnancy such as gestational hypertension, high-risk pregnancies (e.g. multiparity and intrauterine growth retardation), abnormality of placenta and umbilical cord will be excluded. Contraindications to spinal anesthesia e.g. patient's refusal for spinal anesthesia, blood coagulopathies, infection in the anesthesia area, bleeding or hypovolemic shock are other exclusion criteria.
Intervention groups
In each group, in case of hypotension (drop in systolic blood pressure more than 20% of the patient's baseline blood pressure), ephedrine bolus 10 mg or norepinephrine bolus 10 μg is injected.
Comparison of the effect of Norepinephrin and Ephedrine in the treatment of hypotension due to spinal anesthesia in cesarean section on fetal umbilical cord pH - A double-blinded randomized controlled trial
Public title
Comparison of the effect of Norepinephrin and Ephedrine in the treatment of hypotension due to spinal anesthesia in cesarean section on fetal umbilical cord PH
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women
Age 20 to 35 years
Candidate for elective cesarean section
Singleton pregnancy
Gestational age 36 to 40 weeks
Exclusion criteria:
History of hypertension (>140/90)
History of cardiovascular or cerebrovascular diseases
Gestational hypertension
History of high-risk pregnancies (e.g. multiparity or intrauterine growth retardation)
Abnormalities of the placenta and umbilical cord
Contraindications to spinal anesthesia (patient refusal for spinal anesthesia, coagulopathies, infection in the anesthesia area, bleeding or hypovolemic shock)
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with different block sizes will be used to randomly assign two groups with 24 participants in each group (48 patients in total). The size of the blocks will be a multiple of 2 and a divisor of 48. Initially, the block sizes are chosen randomly. Then, for each block, different permutations are randomly determined by the Randomization Allocation Software. In each block, the number of patients in the groups is equal, and blinding is used to not reveal the permutations in the last patients of each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted in a double-blind manner. The patients will be blind to type of injected medicine. Only the anesthesiologist will be aware of patient allocation and will control the condition of the patients during anesthesia. Outcomes will be collected in checklists by one of the researchers who is not aware of the patients' allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of medicine - Iran university of medical sciences (Research Ethics Committee)
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-08-06, 1401/05/15
Ethics committee reference number
IR.IUMS.FMD.REC.1401.262
Health conditions studied
1
Description of health condition studied
Hypotension induced by spinal anesthesia in cesarean section
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anesthesia during labor and delivery
Primary outcomes
1
Description
Umbilical artery pH level
Timepoint
Immediately after delivery
Method of measurement
Biochemical tests
2
Description
Umbilical artery lactate level
Timepoint
Immediately after delivery
Method of measurement
Biochemical tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus norepinephrine will be injected.
Category
Treatment - Drugs
2
Description
Control: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus ephedrine will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi educational and therapeutic center
Full name of responsible person
Ali Mazouri
Street address
Ferdous Garden Station, Molvi St., Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
+98 21 5563 8012
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keyvan
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
+98 21 8862 2703
Email
info@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazouri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hemmat express
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2293 9996
Fax
+98 21 5562 8166
Email
mazouri.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazouri
Position
Assistance Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Iran university of medical sciences - Hemmat express- Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2293 9996
Fax
+98 21 5562 8166
Email
mazouri.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Mazouri
Position
Assistance professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Iran university of medical sciences - Hemmat express, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2293 9996
Fax
+98 21 5562 8166
Email
mazouri.a@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available