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CTRI Number  CTRI/2018/12/016644 [Registered on: 13/12/2018] Trial Registered Prospectively
Last Modified On: 15/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Perfusion Index as a marker of depth of anaesthesia 
Scientific Title of Study   Evaluation of Perfusion Index as a determinant of depth of anaesthesia: Correlation with Minimum Alveolar Concentration and Bispectral Index. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suraj Deepak Desai 
Designation  Post graduate student in MD anaesthesiology 
Affiliation  Maulana Azad Medical College 
Address  Suraj D Desai, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002
Suraj D Desai, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone  9008726991  
Fax    
Email  soorajdesai57@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anju R Bhalotra 
Designation  Director Professor in Department of Anaesthesia and intensive care, Maulana Azad medical college 
Affiliation  Maulana Azad Medical College 
Address  Anju R Bhalotra, room no-312, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002
Anju R Bhalotra, A-1/59, Safdarjung enclave New Delhi-110029
Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Suraj Deepak Desai 
Designation  Post graduate student in MD anaesthesiology 
Affiliation  Maulana Azad Medical College 
Address  Suraj D Desai, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002
Suraj D Desai, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone  9008726991  
Fax    
Email  soorajdesai57@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad medical college and associated hospitals, Bahadur Shah Zafar Marg New Delhi-110002 
 
Primary Sponsor  
Name  Suraj Deepak Desai 
Address  Suraj D Desai, Department of Anaesthesiology, B L Taneja Block, MAMC campus Bahadur Shah Zafar Marg, New Delhi-110002 
Type of Sponsor  Other [] 
 
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 Suraj Deepak Desai  Maulana Azad medical college  Department of anaesthesiology, LOK NAYAK HOSPITAL, OT BLOCK, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI 		 9008726991
9008726991
soorajdesai57@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
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  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II
2. Anticipated duration of surgery 30-120 minutes 
 
ExclusionCriteria 
Details  1. Patients diagnosed with peripheral artery disease, hypertension, cardiovascular disease.
2. Known conditions affecting peripheral perfusion like coarctation of aorta etc..
3. Patients with obesity, anticipated difficult airway.
4. History of long standing Diabetes mellitus
5. Patients on chronic drug therapy, drug/alcohol abuse
6. Patients who have any contraindication to the planned anaesthesia technique
7. Anticipated surgical blood loss>10% of blood volume
8. Pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Perfusion Index and MAC at certain defined time points.  T0 - (Baseline - after application of monitoring devices)
T1 - Preinduction - after sedation with midazolam and fentanyl)
T2 - Postinduction - after loss of verbal response
T3 - Just prior to inserting SGD
T4 - During airway manipulation
T5 - At time of surgical incision
T6 - Fifteen minutes after surgical incision.
T7 - During recovery; at 0.5 MAC
T8 - During recovery; at 0.3 MAC
T9 - At the return of response to verbal commands. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Bispectral Index, Heart Rate, Mean arterial pressure  T0 - (Baseline - after application of monitoring devices)
T1 - Preinduction - after sedation with midazolam and fentanyl)
T2 - Postinduction - after loss of verbal response
T3 - Just prior to inserting SGD
T4 - During airway manipulation
T5 - At time of surgical incision
T6 - Fifteen minutes after surgical incision.
T7 - During recovery; at 0.5 MAC
T8 - During recovery; at 0.3 MAC
T9 - At the return of response to verbal commands. 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2018 
Date of Study Completion (India) 01/01/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/01/2020 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not Yet 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data to be requested at email soorajdesai57@gmail.com and then will be provided by the investigators.

  6. For how long will this data be available start date provided 15-10-2021 and end date provided 15-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - None
Brief Summary
Modification(s)  		 Purpose of the trial- To find if there is correlation between Perfusion Index, Bispectral Index and Minimum Alveolar Concentration.
Background and findings- After noting baseline Perfusion Index, Bispectral Index and Minimum Alveolar Concentration, heart rate and MAP, standard General Anaesthesia will be administered to the patients. Values of the same parameters are noted at different time points. The results are out and we found that perfusion index and MAC correlate well at certain time points of study.
 
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