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CTRI Number  CTRI/2015/10/006242 [Registered on: 06/10/2015] Trial Registered Retrospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of phenylepherine on spinal block for cesarean section. 
Scientific Title of Study   Effect of intravenous phenylepherine infusion on the ED50 of intrathecal plain bupivacaine with fentanyl for cesarean section 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aanchal Kakkar 
Designation  Assistant Professor 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Shahdra

New Delhi
DELHI
110095
India 
Phone  9899368080  
Fax    
Email  kakkaraanchal2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aanchal Kakkar 
Designation  Assistant Professor 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Shahdra
Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Shahdra
New Delhi
DELHI
110095
India 
Phone  9899368080  
Fax    
Email  kakkaraanchal2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aanchal Kakkar 
Designation  Assistant Professor 
Affiliation  University College of Medical Sciences and GTB Hospital 
Address  Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Shahdra
Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur Hospital, Shahdra
New Delhi
DELHI
110095
India 
Phone  9899368080  
Fax    
Email  kakkaraanchal2@gmail.com  
 
Source of Monetary or Material Support  
University College of Medical Sciences and Guru Teg Bahadur Hospital, Shahadra, Delhi. 110095 
 
Primary Sponsor  
Name  University College of Medical Sciences and GTB Hospital 
Address  Dilshad Graden Delhi 
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 Asha Tyagi  UCMS & GTB Hospital  Shahdra,Dilshad Garden, 110095
East
DELHI 		 9818606404

drashatyagi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GTBH Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  pregnant patients undergoing LSCS, (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Infusion  Prophylactic infusion of phenylepherine to prevent post spinal hypotension during LSCS 
Comparator Agent  infusion  Therapeutic bolus of phenylepherin to treat post spinal hypotension during LSCS (as done routinely) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  ASA physical status I or II and an uncomplicated singleton pregnancy of 37 weeks or greater gestation undergoing elective LSCS will be included.  
 
ExclusionCriteria 
Details  Patients with extremes of height or weight (body mass index <20 kg/m2 or >35 kg/m2, height <145 cm or >180 cm),those who refuse consent, or with pregnancy induced hypertension, history of diabetes mellitus, cardiovascular or cerebrovascular diseases, fetal abnormalities or any contraindication to combined spinal epidural block will also be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The dose of intrathecal plain bupivacaine  After Sub-arachnoid block, the spinal block both sensory and motor characteristics will be assessed at every 3 minutes for 15 minutes for adequacy of intrathecal dose 
 
Secondary Outcome  
Outcome  TimePoints 
Umbilical artery pH and Apgar scoring  Umbilical Artery pH at birth.
Apgar scoring at birth and 5 minutes after birth 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/10/2015 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Post-spinal hypotension is a major concern during cesarean section following its adverse maternal and fetal consequences. Phenylephrine is now well established as a first line of vasopressor for management of post-spinal hypotension in obstetric patients. There is some evidence to show that phenylephrine infusion when used for prevention of the post-spinal hypotension, as compared to ephedrine, results in a decreased rostral spread of intrathecal plain levo bupivacaine and hyperbaric bupivacaine. The decreased spread of intrathecal hyperbaric bupivacaine did not translate to an increase in its dose requirement. For intrathecal plain bupivacaine there is no existing study evaluating whether phenylephrine infusion alters its dose requirement. the present study aims to evaluate the dose requirement of intrathecal plain bupivacaine for elective cesarean section, with and without phenylephrine infusion. 

 

 
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