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CTRI Number  CTRI/2024/11/076353 [Registered on: 07/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study on different doses of vasapressor (phenylephrine) in treating hypotension in pregnancy induced hypertensive women undergoing casearean section under spinal block 
Scientific Title of Study   A comparison of different doses of phenylephrine bolus injections in treatment of post spinal hypotension in pre eclampsia patients undergoing LSCS- RCT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sankar R Nair 
Designation  Post graduate 
Affiliation  Bangalore medical college and research institute 
Address  Department of anesthesia Bangalore medical college kalasipalaya bangalore

Bangalore
KARNATAKA
560002
India 
Phone  8848409478  
Fax    
Email  sankaran2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nethra H N  
Designation  Associate Proffesor 
Affiliation  Bangalore medical college and research institute 
Address  Department of anesthesiology , BMCRI , Bangalore 560002

Bangalore
KARNATAKA
560002
India 
Phone  9902317865  
Fax    
Email  drnethrahn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nethra H N  
Designation  Associate Proffesor 
Affiliation  Bangalore medical college and research institute 
Address  Department of anesthesiology , BMCRI , Bangalore 560002

Bangalore
KARNATAKA
560002
India 
Phone  9902317865  
Fax    
Email  drnethrahn@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute kalasipalay bangalore karnataka india 560002  
 
Primary Sponsor  
Name  Bangalore medical college and research institute 
Address  Bangalore medical college and research institute Krishna rajendra road kalasipalaya Karnataka 560002 
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 
Dr sankar r  Bangalore medical college and research institute  department of anesthesia / obstretics division/ vani vilas hospital bangalore medical college.
Bangalore
KARNATAKA 
8848409478

sankaran2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, (2) ICD-10 Condition: O140||Mild to moderate pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  phenylephrine  injection of 50 mcg of fixed dose of phenylephrine to treat post spinal hypotension in pregnant patients with pre eclampsia undergoing LSCS under spinal anesthesia .maximum upto 3 doses will be given in 2 minute intervals  
Comparator Agent  phenylephrine  injection of 75 mcg of fixed dose of phenylephrine to treat post spinal hypotension in pregnant patients with pre eclampsia undergoing LSCS under spinal anesthesia  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patient providing written informed consent voluntarily
patient of 19-40 yrs
American society of anesthesiologist grade 2
patient newly diagnosed to have Pre-eclampsia
patient of pre eclampsia on treatment
patient with weight 50- 80 kgs
height of 150 - 170cm
patient with pre eclampsia undergoing elective or emergency lower segment cesarean section in uncomplicated pregnancies under spinal anesthesia
patient who develop hypotension following spinal anesthesia 
 
ExclusionCriteria 
Details  Patients with ASA III or higher
Allergic to the study drug
Complicated Pregnancies -Multiple pregnancy, preterm LSCS, umbilical cord prolapse, HELLP, Eclampsia, Antepartum hemorrhage
Bad obstetric history
Inadequate level of spinal anesthesia
Fetal growth restriction (estimated fetal weight less than 3rd centile for given gestational age [8])
Pre-existing HTN, Cerebral disease, Raised ICP, Severe PIH
GDM, Epilepsy, Cardiac disease, Congestive heart failure
resting heart rate less than 60 bpm
Fetal anomalies in obstetric scans

 
 
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 
Number of episodes of hypotension after giving the first dose of phenylephrine   Blood pressure , heart rate , saturation will be monitored at an interval of 3 mins 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in MAP following the first dose of phenylephrine  MAP measured immediately after administration of phenylephrine and and after 3 minutes of admisnistration 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   24/11/2024 
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  

Hypotension following spinal anesthesia in obstetric patients is a common complication with incidence as high as 80 percent. Unless urgently treated, it might lead to fetal hypoxic stress and acidosis due to reduced uteroplacental blood flow and reduced cardiac output in mother with catastrophic effects on both mother and fetus..

Vasopressors are the mainstay in the management of hypotension associated with spinal anesthesia. Commonly used vasopressors are Ephedrine, Mephenteramine and phenylephrine with different benefits. Phenylephrine, a pure alpha agonist is the first line vasopressor in treatment of hypotension in normotensive patients , both as bolus and infusion. Phenylephrine boluses in dose range of 50-100µg have been used in both normotensive and pre eclamptic patients but the optimum dose is not yet proved. High doses are reported to cause maternal hypertension, bradycardia and decrease in cardiac output whereas lower dose may be associated with repeated dosing . Compared to healthy patients, the dose requirement of phenylephrine in pre eclamptic patients is expected to be lower due to smaller fetus and diffuse endothelial dysfunction with decreased synthesis of vasodilators but increased sensitivity of vasoconstrictors .

There is inadequate literature on the effective dose of phenylephrine as bolus injection in preeclampsia patients to treat post spinal hypotension. Hence, we intend to study two different doses of phenylephrine bolus injections in treatment of post spinal hypotension in Pre-eclampsia patients undergoing LSCS.

 

 
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