| CTRI Number |
CTRI/2024/10/074960 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Determining the Role of Perfusion Index in Predicting Successful Subarachnoid Block. |
|
Scientific Title of Study
|
To find out cutoff change in perfusion index as a predictor of successful subarachnoid block : A prospective observation 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 |
Kiran Suman |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal
MADHYA PRADESH
462020
India
Bhopal MADHYA PRADESH 462020 India |
| Phone |
7607444844 |
| Fax |
|
| Email |
kiran7607@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal
MADHYA PRADESH
462020
India
Bhopal MADHYA PRADESH 462020 India |
| Phone |
9425609647 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Jai Prakash Sharma |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020 Bhopal
MADHYA PRADESH
462020
India
MADHYA PRADESH 462020 India |
| Phone |
9425609647 |
| Fax |
|
| Email |
jaiprakash.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Bhopal, Madhya Pradesh, India, 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Jai Prakash Sharma |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, Madhya Pradesh, India, 462020
MADHYA PRADESH
462020
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kiran Suman |
AIIMS Bhopal |
Modular Operation Theatre, Department Of Anesthesiology, AIIMS Bhopal
Bhopal
MADHYA PRADESH Bhopal MADHYA PRADESH |
07607444844
kiran7607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals aged between 18 and 70 years.
2.Both male and female patients are eligible.
3.Patients administered subarachnoid block for anesthesia.
4.patients classified as American society of Anesthesiologists(ASA) physical
status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1.Patients with autonomic neuropathy.
2.Individuals with limb vascular abnormalities.
3.Subjects whose PI signal was lost during measurements are excluded from the study.
4.Patients with coagulation disorders.
5.Those categorized as ASA physical status classification 3 and 4
6.Individuals diagnosed with peripheral vascular disease.
7.Patients with contraindications to SAB.
8.Patient refusal. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the changes in Perfusion Index (PI) values during subarachnoid block as a predictor of subarachnoid block
2) To record the conventional pin prick method to predict the success of subarachnoid block
3) To evaluate and compare the predictability of success of subarachnoid block by both methods. |
2min 4min 6min 8min 10min 12min 16min 20min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To record haemodynamic parameters (HR, SBP, DBP & MAP) in both the groups |
2min 4min 6min 8min 10min 12min 16min 20min |
|
|
Target Sample Size
|
Total Sample Size="101" Sample Size from India="101"
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)
|
10/10/2024 |
| 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
|
|