| 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
|
|
|
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
|
|
|
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 |