| CTRI Number |
CTRI/2023/10/058316 [Registered on: 05/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Relation of perfusion index with incidence of hypotension during spinal anesthesia in patient undergoing caesarean section. |
|
Scientific Title of Study
|
An observational study to assess predictive role of perfusion index for hypotension during spinal anesthesia for caesarean section in department of anesthesia at sms hospitals, Jaipur. |
| 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 Rajni Mathur |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
Jaipur
RAJASTHAN
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
rajnimathur@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Mathur |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
Jaipur
RAJASTHAN
India
RAJASTHAN
302004
India |
| Phone |
9829357194 |
| Fax |
|
| Email |
rajnimathur@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naman Jain |
| Designation |
Junior Resident |
| Affiliation |
Sawai Man Singh Medical College and Attached Hospitals |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302004
India |
| Phone |
8147364649 |
| Fax |
|
| Email |
namanjain65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology Second Floor Dhanvantri Complex S M S Medical College
Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department Of Anaesthesiology Second Floor Dhanvantri Complex
S M S Medical College Jaipur |
| 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 Rajni Mathur |
Sawai Man Singh Medical College and Attached Hospitals |
Department Of
Anaesthesiology
Second Floor Dhanvantri Complex
Jaipur
RAJASTHAN |
9829357194
rajnimathur@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient undergoing caesarean section under spinal anesthesia.
Patients consenting to participate.
Adult patients aged 20-35 Years.
Patients belonging to American Society of Anesthesiologists (ASA) grade II.
Weight 50-80 kgs. |
|
| ExclusionCriteria |
| Details |
Parturient with
Placenta praevia
Cardiovascular or cerebrovascular disease
Preeclampsia
Body mass index greater than 40
Gestational diabetes mellitus
Gestational age less than 37 weeks and more than 41 weeks
Contraindications to regional anaesthesia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out whether baseline Perfusion index can be used to predict hypotension
following spinal anesthesia for the caesarean section. |
90 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the correlation between baseline perfusion index and other
hemodynamic parameters following Spinal anesthesia in patients undergoing
caesarean section |
90 mins |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
10/10/2023 |
| 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="8"
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
|
Our aim is to find out whether baseline Perfusion index can be used to predict hypotension
following spinal anesthesia for the caesarean section and to find out the correlation between baseline perfusion index and incidence of
hypotension following Spinal anesthesia in patients undergoing caesarean section. |