Protocol summary

Study aim
Determining the comparative effect of hemodynamic changes due to prophylactic administration of phenylephrine in three forms of bolus, subcutaneous and infusion in mothers with elective cesarean section under spinal anesthesia with marcaine
Design
A clinical trial study on three intervention groups receiving phenylephrine in the form of bolus, subcutaneous and infusion with the control group. There are 30 people for each group. The study is a blind and randomized block study.
Settings and conduct
Background: Anesthesia Location: Operating room of Ilam city hospitals Methods: Evaluation of hemodynamic changes before, during and after prophylactic phenylephrine injection and also in the control group method : Subcutaneous: 5 to 10 minutes before anesthesia, 5 mg phenylephrine at the site of deltoid Infusion: 1 to 2 minutes before anesthesia µg / kg / min0.15 phenylephrine for 30 minutes Bolus: 1 to 2 minutes before anesthesia 1/5 µg / kg Control group: no injection and in cases with pressure drop phenylephrine bolus and stat How to blind: The researcher does not know about the intervention performed for each case when recording data
Participants/Inclusion and exclusion criteria
Inclusion: Single term pregnant women 18 to 35 years old at the risk of anesthesia I and II of the American Anesthesia Association who are candidates for elective cesarean section Exclusion: Women with a history of high blood pressure (BP> 140/90), diabetes, cardiovascular and cerebral disease, known fetal abnormalities, any contraindications to spinal anesthesia, and mothers at the beginning of the labor phase
Intervention groups
Bolus, infusion, subcutaneous and control in 3 intervention groups, prophylactic administration is performed, but not in the control group
Main outcome variables
Blood pressure ; Heart beat ; Apgar score; Arterial blood test results including PH, Paco2, Base excess and HCO3

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200725048206N1
Registration date: 2020-08-20, 1399/05/30
Registration timing: registered_while_recruiting

Last update: 2020-08-20, 1399/05/30
Update count: 0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Majid Aftabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 1999
Email address
majidaftabi73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-31, 1399/05/10
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the comparative effect of hemodynamic changes due to prophylactic Prescription of phenylephrine in three forms: bolus, subcutaneous and infusion in mothers with selective cesarean section under spinal anesthesia with marcaine
Public title
Evaluation of the effect of phenylephrine in cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women Term Single pregnancy Elective cesarean section candidate
Exclusion criteria:
History of hypertension (BP> 140/90 Diabetes Cardiovascular and cerebral disease Recognized fetal anomaly Any contraindication to spinal anesthesia Mothers who are at the beginning of the labor phase
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
After completing the baseline assessment, patients were divided into three intervention groups and one control group. Randomization was performed using the block method (with block size of 4 or 6 and allocation ratio of 1: 1). Block randomization is used to reduce bias and achieve equilibrium in allocating participants to the study groups. Random allocation concealment was performed using opaque sealed envelopes with random sequences. Random allocation sequence is done using a computer-generated Kendall and Smith random number table. These tables have random numbers in both row and column directions, usually up to 99 rows and columns, and row and column digits. The cells are placed in five-digit blocks next to each other and separately to facilitate its use. This step is performed by a statistician who is not part of the research team. The random allocation sequence was hidden in closed opaque envelopes so that participants were assigned to 4 groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The anesthesiologist and other members of the treatment staff and participants in the study are informed but the researcher is not As follows: Participants will be notified upon consent According to the decision of the anesthesiologist, one of the intervention methods is selected and after the prescription, the researcher, who is not aware of the prescription method, starts recording the data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences Campus , Banganjab, Research Blvd. , Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2020-07-14, 1399/04/24
Ethics committee reference number
IR.MEDILAM.REC.1399.140

Health conditions studied

1

Description of health condition studied
Hemodynamics of pregnant women under spinal anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood pressure
Timepoint
Base and minutes 5 and 15 and 30 and 60 and 90 and 120
Method of measurement
Cardiac monitor machine and blood pressure meter

2

Description
Heart rate
Timepoint
Base and minutes 5 and 15 and 30 and 60 and 90 and 120
Method of measurement
Cardiac monitor machine and pulse oximeter

3

Description
Apgar score
Timepoint
Minutes 1 and 5
Method of measurement
Physical examination

4

Description
Umbilical cord blood Paco2 test
Timepoint
After birth
Method of measurement
Laboratory instruments

5

Description
Umbilical cord blood HCO3 test
Timepoint
After birth
Method of measurement
Laboratory instruments

6

Description
Umbilical cord blood pH test
Timepoint
After birth
Method of measurement
Laboratory instruments

7

Description
Umbilical cord blood Base excess test
Timepoint
After birth
Method of measurement
Laboratory instruments

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Bolus method: For patients who are going to receive bolus prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 1.5 µ g / kg of phenylephrine is injected 1 to 2 minutes before anesthesia. If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 µg of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed.
Category
Prevention

2

Description
Intervention group 2: Infusion method: For patients who are going to receive infusion prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 0.15 g / kg / min phenylephrine is injected intravenously for 30 minutes 1 to 2 minutes before anesthesia . If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 g of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. In the infusion group, the drug is discontinued if the systolic blood pressure increases by more than 20% of baseline.
Category
Prevention

3

Description
Intervention group 3: subcutaneous: For patients who are supposed to receive subcutaneous prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 5 to 10 minutes before anesthesia, 5 mg of phenylephrine is injected into the deltoid site. In case of systolic blood pressure drop by 20% the base of systolic blood pressure is given alternately 50 µg of intravenous phenylephrine. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed.
Category
Prevention

4

Description
Control group: In patients in the control group who do not receive phenylephrine (Beacon Pharmaceuticals Ltd), in case of systolic blood pressure drop of less than 20% of baseline or less than 100 mm Hg, they receive µg/kg 1/5 of phenylephrine in bolus and STAT, and in case of drop again the dose is repeated
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital of Ilam
Full name of responsible person
Dr Tayyebe rashidian
Street address
Shahid Beheshti Blvd., Reporter Blvd.
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7144
Email
info@medilam.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr Mohammad Karimian
Street address
Ilam University of Medical Sciences Campus , Research Blvd.,Bangangab
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Majid Aftabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Tajarian Alley 1 , Tajarian St , Chalimar Town
City
Ilam
Province
Ilam
Postal code
6931134573
Phone
+98 84 3222 1999
Email
majidaftabi73@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Majid Aftabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Chalimar Town , Tajarian St , Tajarian 1 Alley
City
Ilam
Province
Ilam
Postal code
6931134573
Phone
+98 84 3222 1999
Email
majidaftabi73@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Majid Aftabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Tajarian Alley , Tajarian St , Chalimar Town
City
Ilam
Province
Ilam
Postal code
6931134573
Phone
+98 84 3222 1999
Email
majidaftabi73@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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