| CTRI Number |
CTRI/2024/09/074267 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting low blood pressure with blood flow readings after Propofol injection |
|
Scientific Title of Study
|
Prognostic power of Perfusion index(PI) in predicting hypotension following Propofol induction |
| 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 Arnab Kundu |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology Kasturba Medical College
Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8787571174 |
| Fax |
|
| Email |
arnab96.kundu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumara |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8970213332 |
| Fax |
|
| Email |
vijaya.kumara@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayakumara |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8970213332 |
| Fax |
|
| Email |
vijaya.kumara@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital
Manipal
Udupi
Karnataka
Pin 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Manipal
Udupi, Karnataka
Pin 576104 |
| 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 Vijayakumara |
Kasturba Hospital and Kasturba Medical College Manipal |
Department of Anaesthesiology
Kasturba Medical College
Manipal
Udupi
Karnataka
Udupi
KARNATAKA |
8970213332
vijaya.kumara@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (4) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, (5) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system, (6) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (7) ICD-10 Condition: N359||Urethral stricture, unspecified, (8) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Physical Status 1 and 2 patients undergoing elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study, Emergency surgeries, Patients
with hypertension, patients with arrythmias, patients on vasoactive medications,
based on WHO criteria), patients with BMI more than 30 kg/m2, patients with peripheral vascular diseases and
long-standing diabetes and pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To use perfusion index as a tool to predict hypotension following propofol induction |
For every 1 minute for 5 minutes from completion of induction and every 1 minute till 10 minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Baseline perfusion index and its correlation with heart rate, systolic blood pressure and diastolic blood pressure |
For every 1 minute for 5 minutes from completion of induction and every 1 minute till 10 minutes post intubation |
|
|
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)
|
21/10/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study aims to determine if the baseline Perfusion Index (PI) can effectively predict hypotension following propofol induction in patients classified as American Society of Anesthesiologists (ASA) Physical Status 1 and 2 starting from post induction every 1minute for 5minutes and every 1 minute for 10 minutes post intubation.This is crucial for enhancing patient safety during anesthesia by establishing a reliable method for monitoring hemodynamic changes.The hypothesis posits that a baseline PI value of less than 1.05 can serve as a reliable predictor for hypotension after propofol induction. The study also seeks to identify new cutoff values for PI and explore its correlation with systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR).This research is significant as it addresses the limitations of traditional noninvasive blood pressure monitoring, which may not capture beat-to-beat variations in perfusion dynamics .
|