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CTRI Number  CTRI/2024/03/063766 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To determine whether Perfusion index can be used as a measurement in pain management during laparoscopic surgeries under general anaesthesia 
Scientific Title of Study   Evaluation of perfusion index as an objective tool to assess analgesia during laparoscopic surgeries under general anaesthesia  
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 Manali Nadkarni 
Designation  Professor 
Affiliation  Seth GS medical college and KEM Hospital 
Address  Dept. Of Urology 8th Floor, New building , Kem Hospital Acharya Donde Marg Parel

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9820235042  
Fax    
Email  manalinad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manali Nadkarni 
Designation  Professor 
Affiliation  Seth GS medical college and KEM Hospital 
Address  Dept of Urology, 8th floor, New building Kem hospital Acharya Donde Marg Parel


MAHARASHTRA
400012
India 
Phone  9820235042  
Fax    
Email  manalinad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anu Joy Palamittam 
Designation  Resident 
Affiliation  Seth GS medical college and KEM Hospital 
Address  1511,,Boys wing, UGPG hostel, Kem Hospital Acharya Donde Marg Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820235042  
Fax    
Email  anupalamittam@gmail.com  
 
Source of Monetary or Material Support  
Kem hospital  
 
Primary Sponsor  
Name  Seth GSMC and KEMH 
Address  Acharya Donde Marg, Parel, Mumbai 400012 
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 Manali Mohan Nadkarni  KEM Hospital  Dept. of Anaesthesia KEM Hospital Acharya Donde Marg, Parel Mumbai 400012, India
Mumbai
MAHARASHTRA 		 9820235042

manalinad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Seth GS MEDICALCollege and KEM Hospital  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 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  ASA class l and class ll
Planned for laparoscopic surgeries under general anesthesia. 
 
ExclusionCriteria 
Details  Patients refusing to participate in the study
Pregnant females
Neurological and psychiatric diseases
Chronic pain disorders,peripheral vascular disorders,ischaemic hearts disorders.
Autonomic dysfunction or drugs affecting the autonomic system. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare changes in the perfusion index to pain stimulus (1st laparoscopic port insertion) & its variability to subsequent pain stimuli (2nd, 3rd & 4th laparoscopic port insertions) after intravenous administration of analgesic dose of fentanyl.  1st laparoscopic port insertion
2nd laparoscopic port insertion
3rd laparoscopic port insertion
Every minute up to first 10 minutes followed by every five minutes up to 30 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To compare corresponding changes in perfusion index with dynamic parameters like pulse rate, non invasive blood pressure, mean arterial pressure & oxygen Saturation  1st ,2nd ,3rd ,4th laparoscopic port insertions
Every one minute for first 10 minutes.
Every five minutes thereafter for next 30 minutes  
 
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)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/02/2024 
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 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  

Anaesthesia is a state of analgesia, unconsciousness, and muscle paralysis.(1)

In order to broaden our knowledge on this concept, a method to quantify nociception is of the utmost importance. Quantification of nociception under anaesthesia is difficult, and therefore, reaction to nociception is used for monitoring it through increased sympathetic activity or the corresponding decreased parasympathetic stimulation (i.e. increased heart rate (HR)(2). Also, Individualized and situationally fitted intraoperative opioid administration by nociception–antinociception balance monitoring helps to avoid opioid overtreatment, opioid-induced hyperalgesia, and adverse effects and shortens the arousal time from anaesthesia.(3,4)

The perfusion index (PI) derived from a pulse oximeter is calculated as the ratio of the pulsatile blood flow to the non-pulsatile blood in peripheral tissue.(5,6) PI can be used to assess peripheral perfusion dynamics due to changes in peripheral vascular tone.(7,8,9) Perfusion index (PI) is a non-invasive and continuous measure of peripheral perfusion.(10,11,12,)The changes in sympathetic tone affect smooth muscle tone and can alter the perfusion, but are not affected by saturation and HR variability.(13-16)We aim to use this parameter to investigate its effectiveness in the assessment of analgesia to painful stimulus under anaesthesia.

 
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