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CTRI Number  CTRI/2025/03/082139 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To check if certain ultrasound parameters in the neck artery can predict fall in blood pressure in pregnant women undergoing cesarean by spinal anesthesia 
Scientific Title of Study   Clinical utility of preoperative bilateral carotid artery corrected flow time (FTc) and carotid artery pulsatility index(PI) for predicting hypotension after spinal anesthesia in parturient undergoing elective caesarean section in tertiary care hospital  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sugandha 
Designation  Junior Resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) 
Address  Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7018773232  
Fax    
Email  drsu4u@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishnu Narayanan M R 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) 
Address  Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  8547442182  
Fax    
Email  vishnu.narayanan.1993@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sugandha 
Designation  Junior Resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER) 
Address  Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  7018773232  
Fax    
Email  drsu4u@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry,605006 
 
Primary Sponsor  
Name  Dr Sugandha 
Address  Department of Anesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),JIPMER Campus Road,Gorimedu,Dhanvantri Nagar,Puducherry,605006 
Type of Sponsor  Other [SELF] 
 
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 Sugandha  Jawaharlal Institute of Postgraduate Medical Education and Research   Department of Anaesthesiology and Critical Care,Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER),JIPMER campus road, Gorimedu, Dhanvantari Nagar, Puducherry 605006
Pondicherry
PONDICHERRY 
7018773232

drsu4u@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee Jipmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All ASA Physical Status II Parturients with singleton pregnancy undergoing elective caesarean section under spinal anesthesia  
 
ExclusionCriteria 
Details  1.Parturient not fit for Spinal Anesthesia
2.Parturient who has cardiovascular conditions like hypertension, arrhythmias, valvular heart disease, or other significant cardiac conditions
3.Parturient with pregnancy-induced hypertension disorder.
4.Parturient on medications that affect cardiovascular function (e.g. beta-blockers, vasodilators, prophylactic vasopressors)
5.Parturient with Carotid stenosis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prediction of post spinal hypotension in pregnant women undergoing cesarean by measuring corrected flow time and pulsatility index of carotid artery  Carotid artery ultrasound measurements will be done preoperatively and maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the relationship between preoperative carotid corrected flow time (FTc) & pulsatility index(PI) with post spinal hypotension index among parturients undergoing elective lower segment caesarean section in tertiary care hospital   Carotid artery ultrasound measurements will be done preoperatively & maternal hemodynamic parameters will be measured from baseline to delivery of the baby in every 1 minute interval 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
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)   09/04/2025 
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  

The parturient scheduled for an elective cesarean section under spinal anesthesia will be recruited after obtaining informed and written consent one day prior to surgery. After being transferred to the operating room, standard ASA monitors will be attached to the parturient. Baseline values of heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be recorded with the table in a left lateral tilt at 15-20 degrees. A high-frequency linear ultrasound probe will be placed over the common carotid artery, approximately 2 cm proximal to the carotid bifurcation, to obtain Doppler waveforms. These measurements will be taken with the table in a left lateral tilt at 15-20 degrees. The data obtained from each side will be used to calculate the corrected flow time interval (FTc) and pulsatility index (PI).Following the ultrasound assessments, the parturient will be positioned for spinal anesthesia, and 0.5% hyperbaric bupivacaine (1.8-2 ml) will be administered. The parturient will then be turned supine with a wedge placed under the right hip. The level of sensory block will be confirmed by the response to cold touch. Systolic blood pressure will be measured at one-minute intervals after spinal anesthesia until the delivery of the baby. Hypotension will be defined as a decrease in systolic blood pressure to less than 100 mmHg or a fall of more than 80% from baseline. Any hypotension will be treated with intravenous vasopressors, and the details of the treatment will be recorded. The obtained data will be analyzed to identify any correlation with post-spinal hypotension.

 
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