| 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
|
|
|
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
|
|
|
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.
|