Protocol summary

Study aim
Determining the effect of norepinephrine infusion on preventing hypotension in spinal anesthesia in women candidates for non-emergency caesarean section
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 is performed on 60 patients. Random allocation software is used for randomization.
Settings and conduct
This study is conducted on women who are candidates for caesarean section under spinal anesthesia in the Kausar operating room of Shahid Sadoughi Hospital, Yazd. 10 minutes before spinal anesthesia, the drug under study or placebo is infused to the patient and up to 10 minutes after the birth of the baby. continues. Hemodynamic variables are measured before drug administration and then every 3 minutes until the end of the drug administration and then every 5 minutes until the end of the surgery and recorded in the questionnaire. This study is double-blind and neither the researcher nor the patient knows the type of drug prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All term pregnant women candidates for non-emergency caesarean surgery aged 20 to 35 and ASA class ll Exit criteria:Lack of patient consent to participate in the study,Severe heart, kidney, lung and liver disease,Pre-eclampsia and eclampsia diseases and,vaginal bleeding and all cases of emergency cesarean section,Use of drugs and psychotropic substances
Intervention groups
Intervention group: In this group, norepinephrine is infused at a dose of 0.01 μg per minute from 10 minutes before spinal anesthesia to 10 minutes after the birth of the baby. Control group: In this group, normal saline is infused with the same volume from 10 minutes before spinal anesthesia to 10 minutes after the birth of the baby.
Main outcome variables
systolic blood pressure; diastolic blood pressure; arterial average; heart rate; Umbilical cord pH; Baby Apgar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100102002963N37
Registration date: 2024-08-19, 1403/05/29
Registration timing: prospective

Last update: 2024-08-19, 1403/05/29
Update count: 0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-21, 1403/06/31
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of norepinephrine infusion to prevent hypotension in spinal anesthesia in women candidates for non-emergency caesarean section
Public title
Investigating the effect of norepinephrine infusion to prevent hypotension in spinal anesthesia in women candidates for non-emergency caesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All term pregnant women candidates for non-emergency caesarean surgery aged 20 to 35 and ASA class ll
Exclusion criteria:
Lack of patient consent to participate in the study Severe heart, kidney, lung and liver disease Pre-eclampsia and eclampsia diseases and vaginal bleeding and all cases of emergency cesarean section Addiction to drugs and psychotropic substances History of using drugs that affect the patient's hemodynamics
Age
From 20 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate 60 eligible applicants, we randomly divide them into two groups of 30 people. For this purpose, we use Random allocation software version 1.0 under Windows to create a sequence, and by using this software we make A list which is specified from 1 to 60 with group A or B treatment By Using this list, we give the first person who is eligible to enter the study, number one and the last person the number 60, then based on the random allocation list and by the software, it is determined which group A or B each person is in. Each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers themselves are unaware of which medication the patient has received, in this way, each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Medical School - Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Faculty of Medicine. Shohadayegomnam Blv.Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Approval date
2024-07-05, 1403/04/15
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403.061

Health conditions studied

1

Description of health condition studied
Hemodynamic variables and hypotension after spinal anesthesia in the women undergoing cesarean section
ICD-10 code
I95.81
ICD-10 code description
Postprocedural hypotension

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

2

Description
Diastolic Blood Pressure
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

3

Description
Mean Arterial Pressure
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

4

Description
Heart Rate
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

5

Description
pH of the baby's umbilical cord
Timepoint
Immediately after birth
Method of measurement
Arterial blood gas analysis

6

Description
Apgar score of the baby
Timepoint
Minutes 1 and 5 after birth
Method of measurement
examination

Secondary outcomes

1

Description
Drop in systolic blood pressure below 90 mm Hg
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

2

Description
Bradycardia(drop in heart rate below 50/ min)
Timepoint
Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery
Method of measurement
Using monitoring device

Intervention groups

1

Description
Intervention group: In this group, norepinephrine is infused at a dose of 0.01 μg per minute from 10 minutes before spinal anesthesia to 10 minutes after the birth of the baby.
Category
Treatment - Drugs

2

Description
Control group: In this group, normal saline is infused with the same volume from 10 minutes before spinal anesthesia to 10 minutes after the birth of the baby.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital, Ebnesina Blv, Safayieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4101
Email
behdad90@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3628 8114
Fax
+98 35 3628 8116
Email
dvc.research@ssu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Faculty member and full professor of Shahid Sadoughi University of Medical Sciences, Yazd
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
0098 35 8231932
Email
drbehdad@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Faculty member and full professor of Shahid Sadoughi University of Medical Sciences, Yazd
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3823 1932
Email
drbehdad@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Shekoufeh Behdad
Position
Faculty member and full professor of Shahid Sadoughi University of Medical Sciences, Yazd
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3823 1932
Email
drbehdad@ssu.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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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