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CTRI Number  CTRI/2026/04/107263 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective 
Study Design  Single Arm Study 
Public Title of Study   A Study to correlate non-invasive Carotid artery ultrasound with fluid responsive index (Pulse Pressure Variation) to guide fluid management during prone position spine surgery 
Scientific Title of Study   Correlation of non-invasive carotid doppler indices with pulse pressure variability based goal-directed hemodynamic therapy in prone-position thoracolumbar and lumbar neurosurgical procedures: a prospective observational study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUNIL JOE JACOB 
Designation  SENIOR RESIDENT, DM NEUROANESTHESIA 
Affiliation  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research 
Address  NEUROANESTHESIA AND CRITICAL CARE, DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9496290441  
Fax    
Email  drsuniljoejacob@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr KIRAN LATA KIRO 
Designation  PROFESSOR 
Affiliation  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research 
Address  NEUROANESTHESIA AND CRITICAL CARE, DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9718592450  
Fax    
Email  kirankiro@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr KIRAN LATA KIRO 
Designation  PROFESSOR 
Affiliation  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research 
Address  NEUROANESTHESIA AND CRITICAL CARE, DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE, 6TH FLOOR ACADEMIC BLOCK, GB PANT HOSPITAL, NEW DELHI

New Delhi
DELHI
110002
India 
Phone  9718592450  
Fax    
Email  kirankiro@gmail.com  
 
Source of Monetary or Material Support  
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, 1-Jwahar Lal Nehru Marg, New Delhi 110002, India 
 
Primary Sponsor  
Name  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research 
Address  Neuroanaesthesia and Critical Care, Department of Anaesthesiology and Intensive Care, GIPMER, New Delhi,110002.  
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 SUNIL JOE JACOB  Govind Ballabh Pant Institute of Postgraduate Medical Education and Research  Room No:17, Neurosurgery OT,2nd floor, A block, GB Pant hospital. New Delhi DELHI
New Delhi
DELHI 
9496290441

drsuniljoejacob@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D321||Benign neoplasm of spinal meninges, (2) ICD-10 Condition: M51||Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders, (3) ICD-10 Condition: A180||Tuberculosis of bones and joints,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All ASA (American Society of Anaesthesiology) physical status I & II patients, scheduled for elective thoracolumbar and lumbar spine surgery in the prone position. 
 
ExclusionCriteria 
Details  •Impaired left ventricular function (ejection fraction less than 50%).
•Moderate to severe valvular disease.
•ECG Rhythm disturbance.
•Carotid artery disease or stenosis more than 50%.
•Basal Metabolic Index (BMI) more than 30 or less than 15 kg m2
•History of cerebrovascular accident or transient ischemic attack.
•Respiratory system disease affecting lung compliance
•Inability to obtain adequate Carotid Doppler signals.
•Severe peripheral arterial occlusive disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Change in FTc and Change in CDPV to fluid bolus
•Change in PPV to fluid bolus
•Correlation between FTc and Change in CDPV with PPV
 
1.5 min after induction (supine)- Baseline.
2.5 min after completion of fluid loading.
3.10 min after stabilisation in prone position and check for fluid responsiveness.
4.5 min after 2nd fluid loading (if responsive) in prone position.
5.Every hour intraoperatively.
6.After completion of surgery, patient in the prone position.
7.5min after making the patient supine.
 
 
Secondary Outcome  
Outcome  TimePoints 
Resistivity Index (RI) trends across intraoperative phase  1.5 min after induction (supine)- Baseline.
2.5 min after completion of fluid loading.
3.10 min after stabilisation in prone position and check for fluid responsiveness.
4.5 min after 2nd fluid loading (if responsive) in prone position.
5.Every hour intraoperatively.
6.After completion of surgery, patient in the prone position.
7.5min after making the patient supine.
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   01/05/2026 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsuniljoejacob@gmail.com].

  6. For how long will this data be available start date provided 24-06-2028 and end date provided 24-06-2038?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This prospective observational study will be conducted in the Departments of Anaesthesiology and Intensive Care in collaboration with Department of Neurosurgery after Institutional Ethics Committee approval. Adult patients undergoing thoracolumbar and lumbar neurosurgical procedures in the prone position will be enrolled following written informed consent. All participants will undergo standard pre-anaesthetic evaluation including detailed history, clinical examination, and review of laboratory and imaging investigations. Routine medications will be continued until the morning of surgery and standard fasting guidelines followed.

In the operating room, standard ASA monitors along with BIS, ABG, TOF, and invasive arterial blood pressure monitoring will be instituted. Anaesthesia will be induced with propofol using target-controlled infusion (Eleveld model), fentanyl, and rocuronium, followed by tracheal intubation. Maintenance will include propofol TCI titrated to maintain BIS 40–60, fentanyl infusion, and rocuronium with volume-controlled ventilation adjusted to maintain normocapnia.

Baseline haemodynamic and Carotid Doppler parameters will be recorded after induction. Fluid preloading with 6 ml/kg hydroxyethyl starch will be administered, followed by reassessment. Patients will then be positioned prone using the dual transverse roll technique, and Carotid Doppler parameters reassessed after stabilization. Carotid Doppler parameters and pulse pressure variation will be recorded hourly until surgery completion. At the end of surgery, patient will be made supine and final measurements will be taken. Neuromuscular blockade will be reversed; trachea will be extubated once patient meets the extubation criteria, and patient will be shifted to Intensive Care Unit (ICU) for further management.

 
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