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CTRI Number  CTRI/2025/03/082042 [Registered on: 10/03/2025] Trial Registered Prospectively
Last Modified On: 09/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of low blood pressure in Elderly patients after giving anaesthesia 
Scientific Title of Study   Evaluation of role of perfusion index as a predictor of post subarachnoid block hypotension in geriatric patients A prospective observational study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR CMS Vineesha 
Designation  Junior Resident 
Affiliation  NIZAM INSTITUTE OF MEDICAL SCIENCES 
Address  FIRST FLOOR, MAIN OPERATION THEATRE DEPT OF ANAESTHESIA NIZAM INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD

Hyderabad
TELANGANA
500082
India 
Phone  9515755713  
Fax    
Email  cmsvineesha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NARMADA PADHY 
Designation  Professor of Anaesthesia 
Affiliation  NIZAM INSTITUTE OF MEDICAL SCIENCES 
Address  FIRST FLOOR, MAIN OPERATION THEATRE DEPT OF ANAESTHESIA NIZAM INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD

Hyderabad
TELANGANA
500082
India 
Phone  9392408465  
Fax    
Email  narmada2000in@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR CMS Vineesha 
Designation  Junior Resident 
Affiliation  NIZAM INSTITUTE OF MEDICAL SCIENCES 
Address  FIRST FLOOR, MAIN OPERATION THEATRE DEPT OF ANAESTHESIA NIZAM INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD

Hyderabad
TELANGANA
500082
India 
Phone  9515755713  
Fax    
Email  cmsvineesha@gmail.com  
 
Source of Monetary or Material Support  
Nizams Institute of Medical Sciences, Hyderabad, Telangana, India 500082 
 
Primary Sponsor  
Name  CMS Vineesha 
Address  FIRST FLOOR, MAIN OPERATION THEATRE DEPT OF ANAESTHESIA NIZAM INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD  
Type of Sponsor  Other [self] 
 
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 CMS Vineesha  Nizams Institute of Medical Sciences  FIRST FLOOR, MAIN OPERATION THEATRE DEPT OF ANAESTHESIA NIZAM INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTA, HYDERABAD
Hyderabad
TELANGANA 
9515755713

cmsvineesha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nizams Institute of Medical Sciences, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.All types of general surgical procedures mainly orthopaedic surgeries that will be conducted under spinal anaesthesia
2.American society of Anaesthesiologists (ASA) physical status I, II, III
 
 
ExclusionCriteria 
Details  1.Cardiac arrhythmia
2.Digital ischemia
3. Allergic reaction to local anesthetic and opiate
4.NYHA III-IV,
5.Uncontrolled hypertension
6.Known cardiac diseases
7.Subarachanoid block above T8 level
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To predict hypotension after spinal anaesthesia with baseline perfusion index   Baseline, at 60 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess relation between perfusion index and hypotension at different time intervals  Upto 60 minutes after spinal anesthesia 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/04/2025 
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="0"
Months="3"
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  

Hypotension is common in elderly patients for surgery under spinal anaesthesia with an incidence of over 50%. Old age is one of main risk factors for  development of hypotension during spinal anaesthesia. The main cause of hypotension is sympathetic block with associated decrease in systemic vascular resistance. The response is exaggerated in elderly due to negative influence of a relatively higher resting sympathetic tone and decreased baroreceptor activity leading to a higher incidence of hypotension. Geriatric patients may have difficulty tolerating the negative effects of hypotension and this may lead to an increased incidence of complications. Therefore, careful consideration and monitoring are essential when using spinal anaesthesia in elderly patients, especially those with pre-existing comorbidities 

Non-invasive blood pressure (NIBP) measurement is the established approach for monitoring intraoperative hemodynamic. The perfusion index is a ratio calculated with pulsatile light absorption over continuous light absorption and gives information about vascular tone and volume status with data obtained from pulse oximeter which is part of a standard anaesthesia monitor. The perfusion index (PI) is defined as the ratio of pulsatile blood flow to non-pulsatile blood flow in the peripheral vascular tissue. It is assessed using a pulse oximeter that measures amount of Infrared light absorbed. The PI serves to evaluate perfusion dynamics and is being considered as a non-invasive means to predict likelihood of hypotension development.This technology was used in the fluid responsiveness in trauma and septic patients, estimating the success of regional anaesthesia, and predicting hypotension in parturient. The standard monitoring site for pulse oximetry is the fingertip, where the normal PI ranges from 0.02% to 20%.

Masimo Signal Extraction Technology (SET) pulse oximetry provides continuous and simultaneous absolute values and trends for PI, arterial oxygen saturation (SaO2), and pulse rate. These values are generated using validated signal extraction technology, which also offers associated alarms to alert medical personnel to any concerning changes in these parameters.

We have planned this study as there are scarce data available regarding efficacy of pulse oximetry-derived perfusion index as predictor of post-spinal hypotension in geriatric patients

 
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