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CTRI Number  CTRI/2020/03/023761 [Registered on: 04/03/2020] Trial Registered Prospectively
Last Modified On: 25/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare 2 medications-Phenylephrine and Norepinephrine to prevent fall in blood pressure caused after giving spinal anaesthesia in patients undergoing Caesarean section.  
Scientific Title of Study   A prospective, randomized double-blinded study to compare Phenylephrine and Norepinephrine infusion to prevent hypotension following Subarachnoid block in patients undergoing Caesarean delivery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Omer Mohammed Mujahid 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,Raipur 
Address  Department of Anaesthesiology, AIIMS Raipur,Tatibandh,Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  963267274  
Fax    
Email  omermohd1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamta Sinha 
Designation  Assistant Professor  
Affiliation  AIIMS, RAIPUR 
Address  Faculty Room No. 01, A Block, AIIMS, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone    
Fax    
Email  drmamta12@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mamta Sinha 
Designation  Assistant Professor  
Affiliation  AIIMS, RAIPUR 
Address  Faculty Room No. 01, A Block, AIIMS, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone    
Fax    
Email  drmamta12@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, Raipur 
 
Primary Sponsor  
Name  AIIMS Raipur 
Address  G. E. Road, Raipur 
Type of Sponsor  Research institution and hospital 
 
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 Omer Mohammed Mujahid  All India Institute of Medical Sciences  A Block, First Floor, Gynae and Obs OT, Department of Anaesthesiology, Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
9632672742

omermohd1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS Raipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O295||Other complications of spinal andepidural anesthesia during pregnancy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion of Norepinephrine  Infusion of Norepinephrine 25mcg/min ( titrated according to blood pressure ) will be given intravenously prophylactically after subarachnoid block. Infusion will be stopped after delivery. 
Comparator Agent  Infusion of Phenylephrine  Infusion of Phenylephrine 2mcg/min ( titrated according to blood pressure )will be given intravenously prophylactically after subarachnoid block. Infusion will be stopped after delivery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Grade 3 and 4 as per Lucas classification of urgency of caesarean section
Pregnant females undergoing Caesarean section under spinal anaesthesia
Age 18-35 years
ASA grade 2
Gestational age more than 37 weeks with singleton pregnancy 
 
ExclusionCriteria 
Details  Not consenting for the study
ASA grades 3,4
Body weight <50kgs,>100kgs
Height<140cm,>170cm
Any pregnancy complications like pregnancy-induced hypertension, gestational diabetes,abruptio placenta,
placenta previa
Any medical diseases like Diabetes mellitus, Hypertension, Cardiac diseases, Severe anemia, Peripheral
vascular diseases.
Failed subarachnoid block
Contraindication to Spinal Anaesthesia
Patients on monoamine oxidase inhibitors and anti-depressants
Spinal Deformities
Diagnosed preoperative fetal compromise 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of post-spinal hypotension in women receiving phenylephrine versus norepinephrine infusion.  Every minute after spinal anaesthesia upto delivery of newborn. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare incidences of maternal bradycardia, fetal acid-base balance, Apgar score and the requirements of vasopressor doses  Every minute after spinal anaesthesia upto delivery of newborn. 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "95"
Final Enrollment numbers achieved (India)="95" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/03/2020 
Date of Study Completion (India) 20/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hypotension following spinal anaesthesia during LSCS is a known entity caused due to the sympathetic nerve blockade where hypotension has been described as a fall in SBP to 80% of baseline. Hypotension can cause nausea,vomiting in the pregnant mother and also potentially cause decreased perfusion to the fetus. Vasopressor drugs have become treatment of choice for both prevention and treatment of hypotension.
Ephedrine has been prophylactically used for preventing hypotension utilising its beta agonist effect.The current standard is to administer a continuous phenylephrine infusion to prevent hypotension. However Phenylephrine which acts by alpha-2 agonist action can cause a reflex fall in heart rate and decreased cardiac output. The use of norepinephrine has been recently thought of as a possible drug to maintain blood pressure following subarachnoid block. And as it has a dual alpha and beta action, it has a lower tendency to cause cardiac depressant effects.

Studies have been done to compare Phenylephrine and Norepinephrine for management of post spinal hypotension with respect to their safety, efficacy and effect on neonatal outcome. But studies comparing manually titrated infusions are very less.
 The primary aim of this study is to compare manual variable titrated infusion of phenylephrine and norepinephrine in preventing post subarachnoid block hypotension.  The secondary aim of this study will be to compare incidences of maternal bradycardia, fetal acid-base balance, Apgar score and the requirements of vasopressor doses.

 
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