Protocol summary

Study aim
Determining and comparing the effect of 5 and 10 μg bolus doses of intravenous norepinephrine on the prevention of hypotension after spinal anesthesia with 0.5% bupivacaine in cesarean section: a double-blind randomized clinical trial
Design
This clinical trial with a control group with parallel, double-blind, randomized, phase 2-3 groups was performed on 126 pregnant patients aged 18-46 years who were candidates for cesarean section and randomization block was used for randomization.
Settings and conduct
Immediately after spinal anesthesia, 42 patients received 5 micrograms of norepinephrine, 42 patients received 10 micrograms of norepinephrine, and 42 patients received 1 ml of normal saline intravenously, then systolic and diastolic blood pressure, mean arterial pressure and heart rate are measured and recorded every two minutes to 10 minutes, then every 5 minutes to 15 minutes and then every 10 minutes until the end of the operation.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Satisfaction to participate in the project; Pregnant patients 18 to 46 years old; Term pregnancy and a candidate for cesarean section under spinal anesthesia. Exclusion Criteria: No spinal anesthesia and induce general anesthesia; Existence of lung and heart diseases and fever; Emergency cesarean section; Eclampsia and preeclampsia; Multiple pregnancies; Contraindications to spinal anesthesia; History of taking ergotamine and an initial systolic pressure of less than 90 mmHg.
Intervention groups
Immediately after spinal anesthesia, patients in groupA, 5 microgram of norepinephrine ( volume of 1 ml) and in group B, 10 micrograms of norepinephrine ( volume of 1 ml) and in group C 1 ml of normal saline as a control group, injected intravenously.
Main outcome variables
Hypotension

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N24
Registration date: 2020-12-26, 1399/10/06
Registration timing: registered_while_recruiting

Last update: 2020-12-26, 1399/10/06
Update count: 0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 5 and 10 μg bolus doses of intravenous norepinephrine on the prevention of hypotension after spinal anesthesia with 0.5% bupivacaine in cesarean section: a double-blind randomized clinical trial
Public title
The effect of Norepinephrine on the prevention of post spinal hypotension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the project Pregnant women aged 18 to 46 and term pregnancy Candidate for cesarean section under spinal anesthesia
Exclusion criteria:
Patients who have failed spinal anesthesia and undergo general anesthesia Lung disease, heart disease, fever, hypertension, diabetes and cardiac arrhythmia Emergency cesarean section due to meconium and fetal distress preeclampsia and eclampsia Multiple pregnancies Contraindications to spinal anesthesia (high ICP, hypovolemia, anemia, coagulation disorders, etc.) History of taking ergotamine Initial systolic pressure less than 90 mmHg
Age
From 18 years old to 46 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Block Randomization method is used as 6 blocks for randomization. In this way, we put 6 pieces of paper with the letter A and 6 pieces of paper with the letter B and 6 pieces of paper with the letter C in a bag and mix them, then for each patient that enters the study, one of the papers is taken out randomly and will be assigned to one of the three groups: A (norepinephrine 5 micrograms), B (norepinephrine 10 micrograms) and group C (normal saline), depending on whether the drawn sheet is either A , B or C. Then, for the next series of patients, the papers are returned to the bag and the same process is repeated until the end of the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
Immediately after spinal anesthesia in group A, 5 micrograms of intravenous norepinephrine ( 1 ml), in group B, 10 micrograms of intravenous norepinephrine ( 1 ml) and in group C, 1 ml normal saline as a control group In similar syringes , which are pre-specified by the anesthesia nurse according to the list, are prepared and injected intravenously.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.UMSHA.REC.1399.374

Health conditions studied

1

Description of health condition studied
Spinal anesthesia in cesarean section
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood pressure
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, and every 10 minutes until the end of the surgery
Method of measurement
Automatic non-invasive blood pressure device

Secondary outcomes

1

Description
Heart Rate
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, and every 10 minutes until the end of the surgery
Method of measurement
pulse oximetry

2

Description
Nausea and Vomiting
Timepoint
During and after surgery
Method of measurement
Observation

3

Description
New born Apgar
Timepoint
1&5 minutes after delivery
Method of measurement
Apgar Score

4

Description
The amount of ephedrine have been consumed
Timepoint
During surgery
Method of measurement
mg

5

Description
The amount of atropine have been consumed
Timepoint
During surgery
Method of measurement
mg

Intervention groups

1

Description
Intervention group1: Immediately after spinal anesthesia in group A, 5 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded.
Category
Prevention

2

Description
Intervention group 2: Immediately after spinal anesthesia in group B, 10 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded.
Category
Prevention

3

Description
Control group: Immediately after spinal anesthesia in group C, one milliliter of normal saline is injected intravenously as a placebo. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

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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