| CTRI Number |
CTRI/2024/11/076257 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Whether Perfusion Index Predicts The Occurrence Of Hypotension After Spinal Anaesthesia |
|
Scientific Title of Study
|
Perfusion Index For Prediction Of Hypotension Following Spinal Anaesthesia: 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 |
Sannidhi |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
Department of Anaesthesia and OT Technology, K. S. Hegde Medical Academy, Deralakatte Post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8497895874 |
| Fax |
|
| Email |
sannidhibhat25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Soori |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Anaesthesiology, Justice K. S. Hegde Charitable Hospital, Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8050152374 |
| Fax |
|
| Email |
rashmisoori@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sannidhi |
| Designation |
Post Graduate |
| Affiliation |
|
| Address |
Department of Anaesthesia and OT Technology, K. S. Hegde Medical Academy, Deralakatte Post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8497895874 |
| Fax |
|
| Email |
sannidhibhat25@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Deralakatte post, Mangalore, Dakshina Kannada, Karnataka, 575018, India |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte post, Mangalore, Dakshina Kannada, Karnataka, 575018, India |
| Type of Sponsor |
Private 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 Rashmi Soori |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology, K. S. Hegde Medical Academy, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8050152374
rashmisoori@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K. S. Hegde Medical Academy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Consenting subjects posted for elective surgery requiring spinal anaesthesia.
Patients aged ≥ 18 years.
Patients with ASA grade I and II. |
|
| ExclusionCriteria |
| Details |
Pregnant ladies.
Peripheral vascular disease.
Non availability of limb for monitoring with pulse oximeter.
Patients who have applied nail polish or henna to the finger nails.
Haemodynamically unstable patients.
Spinal anaesthesia where the level of block has not reached T10. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the association of baseline perfusion index to predict the occurrence of
hypotension following spinal anaesthesia |
1 to 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the onset of spinal anaesthesia by the change in perfusion index |
1 to 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/11/2024 |
| 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="6"
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
|
This study is done to determine the association of baseline perfusion index in predicting the occurrence of spinal anaesthesia induced hypotension and also to determine the onset of block by using perfusion index. |