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CTRI Number  CTRI/2025/10/095796 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 07/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Clinical utility of Carotid Doppler to predict hypotension after spinal anesthesia in Diabetes 
Scientific Title of Study   Clinical utility of change in Carotid artery Corrected Flow time to predict hypotension after spinal anaesthesia in patients with diabetes mellitus. 
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. Alan S Moses 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9489192637  
Fax    
Email  alansmoses2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. V. Stalin 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9786397762  
Fax    
Email  drvstalin@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Alan S Moses 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical Care, JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9489192637  
Fax    
Email  alansmoses2012@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER campus road, Gorimedu, Dhanavantari Nagar, Pondicherry - 605006 
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 Alan S Moses  Jawaharlal Institute of Postgraduate Medical Education and Research  JIPMER hospital, Gorimedu, Dhanavantari Nagar, Pondicherry - 605006
Pondicherry
PONDICHERRY 		 9489192637

alansmoses2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Interventional Studies JIPMER Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||Diabetes mellitus, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  45 degrees leg end elevation   Ultrasound images of the Right Common Carotid artery in a long-axis view will be assessed using a 12-MHz linear-array probe by an experienced anaesthesiologist (who had performed more than 20 carotid scans). The measurement of the flow time would be performed first in supine position (FTc1) followed by 450 leg end elevation (FTc2) with the help of a goniometer. The second reading will be taken after 1 min following leg elevation. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diabetic patients planned for elective surgery under spinal anaesthesia 
 
ExclusionCriteria 
Details  1. Patients who are known cases of Carotid artery stenosis
2. Allergic to Local Anaesthetics
3. Patients taking Anti-Hypertensive drugs
4. Patients on Vaso-dilators
5. Patients having Peripheral Vascular Disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the predictive accuracy of Change in Common Carotid Corrected Flow Time for predicting post-spinal hypotension among diabetic patients undergoing elective surgeries.  every minute until 20 mins after admintistration of spinal anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the usage of vasopressors in post spinal induced hypotension among diabetic patients  every minute until 20 mins after admintistration of spinal anaesthesia 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   27/10/2025 
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="1"
Months="6"
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 diabetic patient scheduled for elective surgery under spinal anaesthesia will be recruited following informed written consent. A thorough preoperative assessment will be done by the attending anaesthesiologist and history of duration of diabetes and current treatment will be obtained. Anthropometric assessment will be done. Routine investigations like RBS, HbA­1c, RFT, CXR and ECG will be reviewed. Premedication and diabetic medications will be prescribed as per department protocol.

 

On the day of surgery, after arrival to the operating room, standard ASA monitors such as SpO2, NIBP, ECG will be attached. Ultrasound images of the Right Common Carotid artery in a long-axis view will be assessed using a 12-MHz linear-array probe by an experienced anaesthesiologist (more than 20 carotid scans). The measurement of the flow time would be performed first in supine position (FTc1) followed by 45 degrees leg end elevation (FTc2) with the help of a goniometer. The second reading will be taken after 1 min following leg elevation. The position of the measurement is around 3 cm proximal to the carotid bulb in the longitudinal plane. The cursor angle will be set parallel to the blood flow direction, and the angle of insonation will be set to less than 60 degrees. The Wodey’s formula will be used for the calculation of FTc. 

After the FTc measurement, patients will be returned to the supine position. Preloading will be done with 10 ml/kg of Ringer Lactate. Spinal anaesthesia will be performed in the left lateral position using 0.5% hyperbaric bupivacaine 15mg (3mL) administered at L3-L4 level. The level of sensory block will be assessed with the help of Cold touch at 5-minute intervals and the highest level attained will be noted. Hemodynamic parameters will be recorded for 20 minutes from the administration of spinal anaesthesia. Hypotension is defined as fall in systolic blood pressure less than 90 mmHg, or reduction in Mean Arterial Pressure by 20% of the baseline value.

 

If any hypotension develops, it would be treated with Inj. Mephenteramine 3 mg boluses. Total vasopressor use for each patient will be noted down. Fall in heart rate to less than 60 bpm will be considered as bradycardia and will be treated with Inj. Atropine 0.12 mg iv.

 
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