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CTRI Number  CTRI/2025/08/093926 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Perfusion Index and Pleth Variability Index as predictors of hypotension following spinal anaesthesia 
Scientific Title of Study   Role of Perfusion Index and Pleth Variability Index as predictors of hypotension following spinal anaesthesia in patients undergoing infraumbilical surgeries. 
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 M SALIM IQBAL 
Designation  PROFESSOR 
Affiliation  Dr. B.R. Ambedkar Medical College  
Address  Department of Anaesthesiology, 1st Floor Major OT, Dr. B.R. Ambedkar Medical College, Kadugondanahalli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DR M SALIM IQBAL 
Designation  PROFESSOR 
Affiliation  Dr. B.R. Ambedkar Medical College  
Address  Department of Anaesthesiology, 1st floor Major OT, Dr. B.R. Ambedkar Medical College, Kadugondanahalli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR M SALIM IQBAL 
Designation  PROFESSOR 
Affiliation  Dr. B.R. Ambedkar Medical College  
Address  Department of Anaesthesiology 1st Floor Major OT, Dr. B.R. Ambedkar Medical College, Kadugondanahalli, Bengaluru

Bangalore
KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Dr BR Ambedkar Medical College  
Address  Dr. B.R. Ambedkar Medical College, Kadugonahalli Bangalore, Karnataka, India- 560045 
Type of Sponsor  Private medical college 
 
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 HARSOOR S S  DR. B.R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  Dr. B.R. Ambedkar Medical College, Kadugonahalli Bangalore, Karnataka, India- 560045
Bangalore
KARNATAKA 		 9845030293

drbramc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE, Dr. B.R. Ambedkar Medical College.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Spinal Anaesthesia  Spinal Anaesthesia given at l3-l4 space using bupivacaine 0.5%-H- 3ml intrathecally and PI and PVI monitored till end of procedure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient aged from 18 to 80 years undergoing elective infra umbilical surgeries under spinal anaesthesia belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) I and II.
 
 
ExclusionCriteria 
Details  Patients who are k/c/o of Hypertension on medication
• Patients with known cardiac comorbidities, abdominal mass.
• Pregnancy
• Patients with contraindication for Spinal Anaesthesia.
• Patients not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Perfusion Index (PI) and Pleth variability index (PVI) to detect hypotension following Spinal anaesthesia   Every 5 minute interval till end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamic changes in correlation with change in Perfusion index (PI) & Pleth Variability Index (PVI),and To study the effect of Ephedrine bolus on Perfusion index (PI) & Pleth Variability Index (PVI) to understand response to sympathomimetic drugs.
 		 At 5 minite intervals till end of surgery 
 
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)   12/09/2025 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-05-2027 and end date provided 01-05-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The baseline PI and PVI will be monitored with the help of Massimo Pulse oximeter by an anaesthesiologist. The PI and PVI will be recorded every 10 seconds for one minute in a supine position on the right index finger at room temperature. The NIBP cuff will always put on the opposite arm. The blood pressure (BP) and HR will be recorded at an interval of one minute for three minutes. The mean of PI, BP, and HR will be taken as the preoperative value.

The patients will then be transferred to the operation theater and standard monitors will be attached, such as electrocardiogram, NIBP, and Massimo pulse oximetry. IV fluid started for the patient at 1.5ml/kg/hr. Spinal anesthesia will be administered by an anaesthesiologist using Quicke’s 25-gauge needle with 15 mg (3 ml) of 0.5% hyperbaric bupivacaine at L3- L4 interspace in the sitting position. The sensory block level will be maintained between T6 and T7 by adjusting the table position. After 20 minutes of spinal anesthesia, maximum cephalad spread will be monitored. If the MAP dropped more than 20% of preoperative reading or when the MAP <60 mmHg (whichever is greater), then it will be regarded as hypotension and treated with a bolus of 6 mg intravenous ephedrine hydrochloride. Bradycardia defined as HR of less than 50 beats/minute and will be managed with 0.6 mg of IV atropine.

The PI, PVI, HR, BP, and SpO2 will be monitored continuously and recorded at five-minute intervals till the end of surgery.

 
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