Evaluation of the effect of norepinephrine, ephedrine and phenylephrine on prophylaxis and treatment of hemodynamic changes of spinal anesthesia in elective Caesarean section surgeries
Comparing the effect of norepinephrine ephedrine and phenylephrine on prophylaxis and treatment of hemodynamic changes of spinal anesthesia such as systolic blood pressure, diastolic blood pressure , pulse rate , nausea and vomiting in elective Caesarean section surgeries
Design
A concealed, randomized, blinded controlled clinical trial with 3 groups design of 45 patients enrolled between March 2021 and August 2021
Settings and conduct
Patients get divided into 3 groups of N, P and E respectively. The patients will be monitored and an iv line for serum therapy will be administered. After receiving 5cc per kilograms of ringer lactate serum spinal anesthesia with proper positioning and sterile preparation with 25 gauge needle with midline approach through L3 - L4 space will be done . According to patients height 0.5 % bupivacaine will be administered. 5 micrograms of norepinephrine in group N , 40 micrograms of phenylephrine in group P and 5 milligrams of ephedrine in group E will be administered the vital signs will be charted every one minute till birth then every 5 minutes till the end of surgery.This sampling is done randomly for the patients who are referred to Rasoul Akram and Firouzgar hospital in Tehran .
Participants/Inclusion and exclusion criteria
Patient consent , age 18 - 40 , height >150 centimeters, gestational age > 36 weeks , weight 60 kilograms - 80 kilograms , no known medical conditions such as hypertension
Intervention groups
The patients will be divided randomly into 3 groups after reviewing the consent papers , basic monitoring and spinal block will be done for each respectively. One of the 3 mentioned drugs will be administered in each group then the vital signs will be charted every 5 minutes.
Main outcome variables
Blood pressure
Heart rate
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210204050243N1
Registration date:2021-05-07, 1400/02/17
Registration timing:registered_while_recruiting
Last update:2021-05-07, 1400/02/17
Update count:0
Registration date
2021-05-07, 1400/02/17
Registrant information
Name
Rima Al Ghozat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2214 7094
Email address
rimaghozat1989@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of norepinephrine, ephedrine and phenylephrine on prophylaxis and treatment of hemodynamic changes of spinal anesthesia in elective Caesarean section surgeries
Public title
Evaluation of the effect of norepinephrine, ephedrine and phenylephrine in treatment of hemodynamic changes in spinal anesthesia in Caesarean section surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent
Gestational age >36 wks
Height>150 cm
Age 18 -40 years
Weight 60 kg - 80 kg
Exclusion criteria:
Spinal block failure
Preeclampsia
History of hypertension
Gestational age of < 36 wks
Multiple gestation
Height < 150 cm
Opium addiction
Contraindication of spinal anesthesia
History of heart disease
Patient discontent
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this current study a permuted block randomization technique will be used in which the randomization will be conducted right before the patients admission. Taking in consideration that 45 patients will be participated in this study which will be divided in 15 blocks each with three sections. First of all 15 blocks each with three sections , in each different methods of treatment included, will be conducted. After forming 15 blocks , all of them will be put in a non transparent envelope and then in a specific vase. Then in each stage an envelope will be selected randomly and will be registered in a predetermined table. For instance, the combination of the first block will be N,P,E in which the first patient will receive the treatment in group N and the second will receive the treatment in group P and the third will receive the treatment in group E, and this will continue until all 15 blocks will be selected. All of these steps will be done before sampling . For allocation concealment, the blocks will be put in a non transparent envelope with no names of the drugs that will be used in this study mention on the envelope. The intervention of the first patient will be unknown until the sampling is completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study in which both the participants and the investigators will not be informed on grouping the patients and the related outcomes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul Akram hospital, Maziyar Mansouri street , Sattar Khan
City
Tehran
Province
Tehran
Postal code
1998733191
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.IUMS.FMD.REC.1399.475
Health conditions studied
1
Description of health condition studied
Hemodynamic changes of spinal anesthesia
ICD-10 code
O74.5
ICD-10 code description
Spinal and epidural anesthesia-induced headache during labor and delivery
Primary outcomes
1
Description
The percentage of women with low blood pressure and heart rate
Timepoint
Right after basic monitoring then every one minute right after the spinal anesthesia is done till the birth and then every five minutes till the end of the surgery
Method of measurement
Blood pressure monitor and pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : Right after spinal anesthesia is done 5 micrograms of norepinephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery.
Category
Prevention
2
Description
Intervention group2: Right after spinal anesthesia is done 40 micrograms of phenylephrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery.
Category
Prevention
3
Description
Intervention group3: Right after spinal anesthesia is done 5 milligrams of ephedrine will be administered then the patient’s vital signs will be documented every one minute till birth then every 5 minutes till end of surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Dr Rima Al Ghozat
Street address
Maziyar Mansouri st, Sattar Khan
City
Tehran
Province
Tehran
Postal code
1998733191
Phone
+98 21 2214 7094
Email
rimaghozat1989@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motevalian
Street address
Iran medical university, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614536
Phone
+98 21 8670 2504
Email
research-m@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
Rima Alghozat
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Rasoul Akram hospital , Maziyar Mansouri St , Sattar Khan