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CTRI Number  CTRI/2024/05/066890 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 05/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluating the role of preanesthetic corrected carotid flow time as a predictor of post spinal hypotension in patients undergoing caesarean section. 
Scientific Title of Study   Preanaesthetic ultrasonographic evaluation of carotid flow time as a predictor of post spinal hypotension in patients undergoing caesarean section. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maria Joby 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  C/O Dr Amit Kohli, Professor, Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi

Central
DELHI
110002
India 
Phone  9873573924  
Fax    
Email  mariajoby137@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kohli 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Dr Amit Kohli, Professor, Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi

Central
DELHI
110002
India 
Phone  9818073402  
Fax    
Email  dramitkohli@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Kohli 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  C/O Dr Amit Kohli, Professor, Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi

Central
DELHI
110002
India 
Phone  9818073402  
Fax    
Email  dramitkohli@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Lok Nayak Hospital, Maulana Azad Medical College, New Delhi- 110002, India 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Department of Anaesthesiology, 3rd floor, B L Taneja block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, 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 Maria Joby  Lok Nayak Hospital  Obstetrics and Gynecology OT, Obstetrics and Gynecology Block, Lok Nayak Hospital and associated G.I.P.M.E.R., Guru Nanak Eye Center, Delhi gate, Jawahar Lal Nehru Marg
Central
DELHI 		 09873573924

mariajoby137@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  American Society of Anesthesiologists(ASA) physical status II 
 
ExclusionCriteria 
Details  1. Absolute and relative contraindications for spinal anaesthesia
2. Patients with history of heart disease
3. Previous valvular or carotid artery surgeries
4. History suggestive of cerebrovascular disease or chronic kidney disease
5. BMI more than 35kgm-²
6. Multiple gestation
7. Antepartum hemorrhage or diagnosed preeclampsia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Sensitivity and specificity of cCFT in prediction of post spinal hypotension in patients undergoing caesarean section.  First 40 minutes from the time of giving spinal anesthesia at every 2 minutes interval. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Sensitivity and specificity of IVCCI in prediction of post spinal hypotension in patients undergoing caesarean section.
2. Sensitivity and specificity of IJVCI in prediction of post spinal hypotension in patients undergoing caesarean section
3. Sensitivity and specificity of CAPVV in prediction of post spinal hypotension in patients undergoing caesarean section
4. Correlation of preanaesthetic cCFT , CAPVV, IJVCI and IVCCI with number of hypotensive episodes and degree of fall in SBP
 		 First 40 minutes from the time of giving spinal anesthesia at every 2 minutes interval. 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   16/05/2024 
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="1"
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   We are assessing the role of neck vessel parameters such as corrected carotid artery flow time, carotid artery peak systolic velocity variation, internal jugular vein collapsibility index and inferior vena cava collapsibility index in prediction of post spinal anesthesia  hypotension in patients undergoing Caesarean section, taking a total sample size of 92.  
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