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CTRI Number  CTRI/2019/12/022505 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 20/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare norepinephrine and phenylephrine infusion to prevent spinal anesthesia induced hypotension 
Scientific Title of Study   Prophylactic efficacy of norepinephrine and phenylephrine infusion against spinal hypotension during lower segment caesarean section:A randomised double-blind controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pachha Priya 
Designation  Junior Resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Science, near cantonment,Ballari
Near cantonment, Ballari Pin 583104
Bellary
KARNATAKA
583104
India 
Phone  9686726117  
Fax    
Email  pachhapriya5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srinivasalu D 
Designation  Professor 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Science, near cantonment,Ballari

Bellary
KARNATAKA
583104
India 
Phone  9845224880  
Fax    
Email  drsrinivasd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pachha Priya 
Designation  Junior Resident 
Affiliation  Vijayanagar Institute of Medical Sciences 
Address  Department of Anaesthesiology, Vijayanagar Institute of Medical Science, near cantonment,Ballari
Near cantonment, Ballari Pin 583104
Bellary
KARNATAKA
583104
India 
Phone  9686726117  
Fax    
Email  pachhapriya5@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Vijayanagar Institute of Medical Sciences 
Address  Near cantonment, Ballari Pin 583104 
Type of Sponsor  Government 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 
DrPachha Priya  Vijayanagar Institute of Medical Sciences  Department of Anaesthesiology, Major OT complex, Vijayanagar Institute of Medical Sciences,Near cantonment ,Ballari, Karnataka pin-583104
Bellary
KARNATAKA 		 9686726117

pachhapriya5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VIMS institutional Ethical Committee   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  Prophylactic infusion of Norepinephrine for control of spinal hypotension  Norepinephrine infusion 5microgram/min iv is started just after spinal anaesthesia in patients undergoing lower segment caesarean section and stopped 10 min after baby extraction 
Comparator Agent  Prophylactic infusion of Phenylephrine after spinal anesthesia  Phenylephrine infusion 50 microgram/min iv is started just after spinal anaesthesia in patients undergoing lower segment caesarean section and stopped 10 min after baby extraction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.American Society of Anesthesiologists physical status 2
2.Singleton term pregnancy
 
 
ExclusionCriteria 
Details  1.Age less than 18 years
2.Height less than 150cm or more than 180cm
3.Weight less than 50kg or more than 100kg
4.Contraindication to spinal anaesthesia
5.Allergy to drugs used in the study
6.Eclampsia,preeclampsia,placenta previa,diabetes mellitus,hypertension,cardiovascular disease or refusal to be in the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypotension  Study parameters are observed and recorded just before spinal anaesthesia and thereafter every minute after spinal anaesthesia until 10 min after baby extraction  
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of hypertension, APGAR score of the baby, bradycardia, tachycardia, nausea and vomitting  Study parameters are observed and recorded just before spinal anaesthesia and thereafter every minute after spinal anaesthesia until 10 min after baby extraction  
 
Target Sample Size   Total Sample Size="190"
Sample Size from India="190" 
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2019 
Date of Study Completion (India) 15/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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 is a common adverse effect observed during caesarean delivery done under sub arachnoid block with incidence being around 71%. This can adversely affect maternal and foetal outcomes in addition to the associated sequelae such as nausea, vomiting. As a result, prevention of spinal hypotension has for long been a prime research area within the field of obstetric anaesthesia.

 Various methods have been employed to prevent this complication. They include fluid preloading /co-loading and prophylactic use of vasopressors.

 Phenylephrine, an alpha agonist is a popular drug for both treatment and prevention of spinal anaesthesia induced hypotension. It reduces the incidence of maternal hypotension with better preservation of other maternal and foetal parameters. Its use is often associated with reflex bradycardia and risk of a reduction in the cardiac output.

 Norepinephrine has predominantly alpha and weak beta receptor agonism with lesser tendency to reduce heart rate and the cardiac output.

 This study is designed to compare the efficacy of prophylactic infusion of 50 µg/min of phenylephrine and 5 µg/min of norepinephrine in the prevention of hypotension caused by subarachnoid block in caesarean section.

 


 
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