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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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  

Participants for the study will be selected based on a thorough preoperative assessment and will be scheduled for lower abdominal or lower limb surgeries. After obtaining informed consent, each participant will undergo a sensory evaluation to establish baseline sensory function. In the operating room, an 18G IV catheter will be inserted, and standard monitoring, including non-invasive blood pressure, ECG, and SpO2, will be implemented. A bolus of 0.9% normal saline will be administered to stabilize hemodynamics before the subarachnoid block. Monitoring will include a pulse oximetry probe on the non-operating limb and skin temperature measurements, with the operating room maintained at 22-24°C. Participants will receive 0.02 mg/kg IV midazolam for sedation. During the subarachnoid block procedure, participants will be positioned sitting, and a subarachnoid puncture will be performed at the L3-L4 or L4-L5 intervertebral spaces with 12.5 to 15 mg of bupivacaine administered. Perfusion Index (PI) will be recorded immediately after the needle is removed. Post-administration, PI, Mean Arterial Pressure (MAP), sensory response to a pin prick test, and motor blockade will be monitored at intervals of 2, 4, 6, 8, 10, 12, 16, and 20 minutes. Surgery will proceed only if a sensory block at the T10 level is confirmed; otherwise, general anesthesia will be used.

 
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