| CTRI Number |
CTRI/2024/06/069553 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Finding the relation between perfusion index with baseline heart rate and fall in blood pressure after giving spinal anaesthesia in pregnant patients under going caesarian |
|
Scientific Title of Study
|
Correlation of perfusion index with baseline heart rate and post spinal hypotension in pregnant patients posted for LSCS - 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 |
Dr. Perni Tharun Dasarath |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesialogy, 5th Floor, Hi-tech building, Dr.D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7396806146 |
| Fax |
|
| Email |
tharundasarathperni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandip Baheti |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College- Hospital and Research Centre,
Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sandip Baheti |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building,
Dr. D.Y.Patil Medical College- Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Perni Tharun Dasarath |
| Address |
Department of Anaesthesialogy,
5th Floor, Hi-tech building, Dr. D.Y.Patil Medical College- Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| 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 PERNI THARUN DASARATH |
Dr. D.Y. Patil Hospital and Research Centre |
Department of
Anaesthesia, 5th Floor,
Hi-tech building, Dr.
D.Y.Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
Pune 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7396806146
tharundasarathperni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee , Dr. Dy patil medical college , hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Its just an observational study.we compare perfusion index ,heart rate and blood pressure before induction and after induction |
and perfusion index , heart rate and blood pressure at every 2 minutes of interval after induction. And we compare with the base line values before induction |
| Intervention |
Spinal anaesthesia in LSCS patirnts |
We check the base line perfusion index , heart rate at every 20 seconds of interval and blood pressure at every 1 minute interval for 3 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 20 to 35 years
2. Gestational age between 36 to 40 weeks
3. Elective LSCS
4. ASA -2 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the chances of hypotension occurring after spinal anaesthesia in patients with low perfusion index and in patients with high perfusion index |
We check the base line perfusion index , heart rate at every 20 seconds of interval and blood pressure at every 1 minute interval for 3 minutes before induction and perfusion index , heart rate and blood pressure at every 2 minutes of interval after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in heart rate occurring after spinal anaesthesia in patients with low perfusion index and in patients with high perfusion index at interval of 2 minutes |
To compare the changes in heart rate occurring after spinal anaesthesia in patients with low perfusion index and in patients with high perfusion index at intervals of 2 minutes |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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
|
To avoid complications of hypotension it is essential to find out a valid method like perfusion index which can predict hypotension. Perfusion index is a useful non invasive method , yet there is not much awareness about clinical use of perfusion among anaesthesiologists. So in this study we will be identifying the correlation of perfusion index with baseline heart rate and post spinal hypotension. It is a prospective observational study. |