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CTRI Number  CTRI/2024/01/061565 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 09/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of the effect of prophylactic bolus of ephedrine versus norepinephrine to prevent post-spinal hypotension during elelctive caesarean section under spinal anaesthesia.  
Scientific Title of Study   Comparison of the effect of prophylactic bolus of ephedrine versus norepinephrine to prevent post-spinal hypotension during elelctive caesarean section under spinal anaesthesia-a randomised controlled double blind study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshata K Hiremath 
Designation  Postgraduate student 
Affiliation  SDM college of Medical Sciences and Hospital  
Address  Department of Anaesthesiology,SDM college of medical sciences and hospital,Dharwad

Dharwad
KARNATAKA
570009
India 
Phone  9035390094  
Fax    
Email  akshatakb97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddesh N Kadur 
Designation  Associate professor 
Affiliation  SDM college of Medical Sciences and Hospital  
Address  Department of Anaesthesiology,SDM college of medical sciences and hospital,Dharwad

Dharwad
KARNATAKA
570009
India 
Phone  9782560622  
Fax    
Email  kadurgolightly@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akshata K Hiremath 
Designation  Postgraduate student 
Affiliation  SDM college of Medical Sciences and Hospital  
Address  Department of Anaesthesiology,SDM college of medical sciences and hospital,Dharwad

Dharwad
KARNATAKA
570009
India 
Phone  9035390094  
Fax    
Email  akshatakb97@gmail.com  
 
Source of Monetary or Material Support  
SDM college of medical sciences and hospital Dharwad 
 
Primary Sponsor  
Name  DrAkshata K Hiremath 
Address  Department of Anesthesiology,SDM College of Medical Sciences and Hospital, Dharwad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshata K Hiremath  SDM college of Medical Sciences and Hospital   Department of Anesthesiology
Dharwad
KARNATAKA 		 9035390094

Akshatakb97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  During spinal anaesthesia, a prefilled 1ml syringe of prophylactic bolus dose of 6 mg (1 ml) Ephedrine will be given.  Patients undergoing elective ceserean section under spinal anaesthesia are selected.During spinal anaesthesia, a prefilled 1ml syringe of prophylactic bolus dose of 6 mg (1 ml) Ephedrine will be given.Systolic and diastolic blood pressure, MAP and HR will be recorded every 2.5 minutes upto the delivery of the baby and then every 5 minutes till the end of surgery. Systolic and diastolic blood pressure, MAP, HR, the number of boluses of vasopressor used and Apgar score at 1 and 5 min in each group will be recorded. 
Comparator Agent  During spinal anaesthesia, a prefilled 1ml syringe of prophylactic bolus dose of 5 μg (1 ml) Norepinephrine will be given.  Patients undergoing elective ceserean section under spinal anaesthesia are selected.During spinal anaesthesia, a prefilled 1ml syringe of prophylactic bolus dose of 5 μg (1 ml) Norepinephrine will be given.Systolic and diastolic blood pressure, MAP and HR will be recorded every 2.5 minutes upto the delivery of the baby and then every 5 minutes till the end of surgery. Systolic and diastolic blood pressure, MAP, HR, the number of boluses of vasopressor used and Apgar score at 1 and 5 min in each group will be recorded. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Willing to participate
ASA class 2
 
 
ExclusionCriteria 
Details  Pregnant women with pre-eclampsia and eclampsia
Baseline bp>140mmhg
BMI>30kg/m2
Comorbid conditions (cardiovascular, renal,hepatic diseases)
Contraindication to spinal anaesthesia like coagulopathy,raised ICP
Failed spinal anaesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Decreased incidence of post spinal hypotension with norepinephrine than ephedrine.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Effective prevention of adverse effects like nausea, vomiting secondary to hypotension & improved neonatal outcome with norepinephrine than ephedrine.  2 years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   20/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Comparision of the effect of prophylactic bolous dose of ephdrine versus norepinephrine to prevent post spinal hypotension in elective caesarean section -a randomised controlled double blind studydone on 50 persons in each group by computer generated randomisation in tertiary care teaching hospital.comparing mean arterial pressure ,heart rate bolus of vasopressors required ,apgar score and episodes of nausea and vomiting betwen two groups. 
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