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CTRI Number  CTRI/2025/10/096713 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Predicting Spinal Anaesthesia-Related Blood Pressure Drops in the Elderly Using Perfusion Index 
Scientific Title of Study   Perfusion Index as a Predictor of post-Spinal Anaesthesia Hypotension in Geriatric Patients: 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  Roshan Andleeb 
Designation  assistant professor 
Affiliation  AIIMS Kalyani 
Address  dept of Trauma &Emergency Medicine AIIMS Kalyani NH 34 connector Basantapur saguna Nadia
nh34 connector basantapur saguna Nadia west bengal 741245
Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Roshan Andleeb 
Designation  assistant professor 
Affiliation  AIIMS Kalyani 
Address  dept of Trauma &Emergency Medicine AIIMS Kalyani NH 34 connector Basantapur saguna Nadia
nh34 connector basantapur saguna Nadia west bengal 741245
Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Roshan Andleeb 
Designation  assistant professor 
Affiliation  AIIMS Kalyani 
Address  dept of Trauma &Emergency Medicine AIIMS Kalyani NH 34 connector Basantapur saguna Nadia
nh34 connector basantapur saguna Nadia west bengal 741245
Nadia
WEST BENGAL
741245
India 
Phone  09045292647  
Fax    
Email  roshan8978@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Kalyani, NH- 34 connector, Basantapur, Saguna, Nadia , west Bengal 741245 
 
Primary Sponsor  
Name  AIIMS Kalyani 
Address  dept. Trauma & Emergency medicine, AIIMS kalyani, NH 34 connector, basantapur, sgauna, Nadia west bengal 741245 
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 Roshan Andleeb  aiims kalyani  dept Trauma & Emergency medicine NH-34 connector Basantapur Saguna Nadia West Bengal 741245
Nadia
WEST BENGAL 
09045292647

roshan8978@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  asa stustus II-III undergoing surgery under spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient with peripheral vascular disease, significant cardiac, renal, pulmonary, hepatic and neurological disease, uncontrolled hypertension, history of brain injury or cerebrovascular disease
Patients on psychiatric medication, especially lithium.
Complex surgical procedures with anticipated substantial fluid shifts and intraoperative hemodynamic instability.
Patients with ASA IV status, BMI more than 30 kg/m2)
Significant cardiac disease ( more than grade II LV diastolic dysfunction, arrhythmia, pacemaker, LV or RV heart failure, ejection fraction less than 50, moderate to severe valvular heart disease)
Contraindications to spinal anaesthesia (bleeding tendency, allergy to local anaesthetics, sepsis, infection of the needle insertion site)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
correlation between baseline PI and post-spinal hypotension
predictive values of the baseline perfusion index for detecting Post spinal anaesthesia hypotension
 
baseline (after a 5-minute stabilization period following monitor attachment), just after administration of spinal anaesthesia, then 2.5-minute intervals for the first 30 minutes and every 5-minute intervals for a further 60 minutes and then at 15 minutes interval till the end of surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
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)   10/11/2025 
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="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  

Post-spinal anaesthesia hypotension increases the risk of morbidity and mortality in elderly compared to the non-elderly population, making it a critical concern in perioperative care for geriatric population. Various modalities have been studied to predict the occurrence of hypotension following spinal anaesthesia, but they are invasive, expensive and need a significant level of expertise. The perfusion index is a simple, non-invasive and cost-effective monitoring tool to monitor peripheral vascular tone and various studies documented its potential as an early predictor of hypotension. Given the increasing number of elderly patients undergoing surgery with spinal anaesthesia, the accurate prediction of post-spinal anaesthesia hypotension is crucial for timely intervention and better patient outcomes, and the perfusion index shows potential as an early indicator of hypotension. However, its predictive accuracy in the geriatric population is not well established. This study aims to evaluate the efficacy of baseline PI as a predictor of post-spinal anaesthesia hypotension in geriatric patients.

After taking informed consent 92 patients of age more than 60 years with ASA II-III patients of either sex  undergoing elective surgery under spinal anaesthesia will be enrolled. Patient  with ASA status IV,  peripheral vascular disease, Significant cardiac disease ( more than grade II LV diastolic dysfunction, arrhythmia, pacemaker, LV or RV heart failure, ejection fraction  less than 50%, moderate to severe valvular heart disease), renal, pulmonary, hepatic and neurological disease, uncontrolled hypertension, history of brain injury or cerebrovascular disease, on psychiatric medication, especially lithium and patients undergoing Complex surgical procedures with anticipated substantial fluid shifts and intraoperative hemodynamic instability and patints having contraindications to spinal anaesthesia (bleeding tendency, allergy to local anaesthetics, sepsis, infection of the needle insertion site) will be excluded. Each patints will receive spinal anaesthesia as per study protocol and PI and other haemodynamic parameters (HR, SBP, DBP. MAP) will be recorded at baseline (after a 5-minute stabilization period following monitor attachment), just after administration of spinal anaesthesia, then 2.5-minute intervals for the first 30 minutes and every 5-minute intervals for a further 60 minutes and then at 15 minutes interval till the end of surgery.

SPSS software or an equivalent program will be used for analysis. The correlation between various parameters will be assessed using the Pearson correlation coefficient for linear relationships and the Spearman correlation coefficient for non-linear relationships. Regression analysis with Spearman’s rank correlation coefficient will be used to assess the correlation between baseline PI with post-spinal hypotension. Multiple linear regression analysis will be performed to explore the relationships between patients’ characteristics and baseline parameters with post-spinal hypotension. A receiver operating characteristic (ROC) curve will be generated for baseline PI compared with hypotension. The area under the curve (AUC) will be calculated to measure the accuracy of the parameter, and the optimal cut-off point, which minimizes false-positive and false-negative rates, will be identified. A significance level of P < 0.05 will be considered statistically significant. A significance level of P < 0.05 will be considered indicative of statistically significant differences.

 

 

 

 
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