| CTRI Number |
CTRI/2025/08/092848 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
We are studying pregnant women having planned caesarean sections under spinal anaesthesia. Using a finger-clip to measure blood flow, we aim to predict and treat low blood pressure early, making surgery safer and more comfortable.
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Scientific Title of Study
|
Perfusion Index and Pleth Variability Index as Non-Invasive Predictors of Hypotension Following Spinal Anaesthesia in Lower Segment Caesarean Section: A Prospective Observational Study |
| Trial Acronym |
Nil |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subasri S |
| Designation |
Postgraduate resident, Department of Anaesthesiology |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry
Ariyur Puducherry
605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9787088779 |
| Fax |
|
| Email |
subashan3333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandraleela MD |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ARIYUR PUDUCHERRY
SRI VENKATESHWARAA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE ARIYUR PUDUCHERRY
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9176529672 |
| Fax |
|
| Email |
drchanduz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChandraleela MD |
| Designation |
Associate Professor |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre ( |
| Address |
Sri Venkateshwaraa Medical College Hospital and Research Centre Ariyur Puducherry
Ariyur Puducherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9176529672 |
| Fax |
|
| Email |
drchanduz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Subasri
Post graduate resident
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur Puducherry 605102
India |
|
|
Primary Sponsor
|
| Name |
Dr Subasri |
| Address |
Post graduate resident Department of Anaesthesiology
Sri Venkateshwaraa Medical College Hospital and Research Centre
Ariyur Puducherry 605102
India |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subasri S |
Departrment of Anaesthesiology,Srivenkateshwaraa medical college hospital and Research centre |
Srivenkateshwaraa medical college hospital and Research Centre Ariyur
Pondicherry
PONDICHERRY |
09787088779
subashan3333@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(HUMAN STUDIES) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
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Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Female |
| Details |
Parturients posted for elective caesarean section under spinal anesthesia.
Age group 20-40 years.
Belongs to ASA class II and III (American society of Anaesthesiologists)
|
|
| ExclusionCriteria |
| Details |
contraindication to spinal anaesthesia
class II obese
cerebrovascular disease
peripheral vascular disease
cardiovascular disease |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Quantify the incidence of hypotension following spinal anaesthesia in parturients undergoing LSCS.
Identify baseline PI and PVI values associated with post –spinal hypotension.
Establish cutoff values of PI and PVI for predicting hypotension with good sensitivity and specificity.
Enable early detection of high risk patients prone for post-spinal hypotension using non-invasive pulse oximetry.
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Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Improve maternal & fetal outcomes by guiding individualized preventive interventions.
Support the use of PI & PVI as practical ,bedside clinical tool in obstetric anaesthesia.
|
Baseline immediately after the procedure as 0 minute,then at 1minute 3minutes6 minutes 9 minutes 12 minutes 15 minutes 25 minutes 35 minutes 45 minutes |
|
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Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
22/08/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This prospective observational study investigates whether Perfusion Index PI and Pleth variability index PVI can predict hypotension following spinal anaesthesia in women undergoing elective caesarean section . In 132 parturients baseline and post spinal PI PVI and hemodynamic changes monitored . The study aims to estabilish PI and PVI as non invasive predictors of post spinal hypotension and correlate them with vasopressor requirement.
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