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CTRI Number  CTRI/2017/10/010134 [Registered on: 18/10/2017] Trial Registered Retrospectively
Last Modified On: 14/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   To measure the adequacy of anaesthesia.  
Scientific Title of Study   Monitoring of depth of Anaesthesia using entropy monitor during Cardiopulmonary bypass- a prospective study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pragya Sachan 
Designation  Post Graduate Resident 
Affiliation  LTMMC and LTMGH Hospital,Dr Babasaheb Ambedkar Road,Sion west,Mumbai-400022 
Address  Dept of Anaesthesia,4th Floor, College Building,LTMMC and LTMGH,Sion,Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9833685303  
Fax    
Email  pragya.sachan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Naina P Dalvi 
Designation  Additional Professor 
Affiliation  HBT Medical College And Dr R N Cooper Municipal General Hospital 
Address  HBT Medical College And Dr. R N Cooper Municipal General Hospital,Bhaktivedanta Swami Marg, Gulmohar Road, Opp Bhagu Bai Polytechnic College,Juhu, Mumbai.

Mumbai
MAHARASHTRA
400056
India 
Phone  9820711656  
Fax    
Email  drnaina@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Naina P Dalvi 
Designation  Additional Professor 
Affiliation  HBT Medical College And Dr R N Cooper Municipal General Hospital 
Address  HBT Medical College And Dr. R N Cooper Municipal General Hospital,Bhaktivedanta Swami Marg, Gulmohar Road, Opp Bhagu Bai Polytechnic College,Juhu, Mumbai.

Mumbai
MAHARASHTRA
400056
India 
Phone  9820711656  
Fax    
Email  drnaina@rediffmail.com  
 
Source of Monetary or Material Support  
LTMMC and LTMGH Hospital,Dr Babasaheb Ambedkar Road,Sion west,Mumbai-400022 
 
Primary Sponsor  
Name  Pragya Sachan 
Address  Dept of Anaesthesia,LTMMC and LTMGH Hospital,Dr Babasaheb Ambedkar Road,Sion west,Mumbai-400022 
Type of Sponsor  Other [Principal investigator] 
 
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 
Pragya Sachan  LTMMC and LTMGH Hospital  Cardiovascularthoracic Surgery Operation Theatre,,Dr Babasaheb Ambedkar Road,Sion west,Mumbai-400022
Mumbai
MAHARASHTRA 		 9833685303

pragya.sachan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-HUMAN RESEARCH,LTMMC,SION,MUMBAI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATENTS POSTED FOR CARDIOPULMONARY BYPASS SURGERY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18-60 years and consenting for monitoring were included in study  
 
ExclusionCriteria 
Details  Patients unwilling and with history of epilepsy,head injury,thromboembolic episodes related or unrelated to cardiac disease were excluded from study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
monitor the depth of
Anaesthesia using Entropy monitor during
Cardiopulmonary bypass on the basis of Numerical Indices provided by Entropy Monitor (Response Entropy {RE} and State Entropy {SE}, Burst Suppression Ratio{BSR}
 		 After 18 months of study. 
 
Secondary Outcome  
Outcome  TimePoints 
Modified Version of Brice Questionnaire used after 48 hrs of Surgery about any
memories or recall of Intra operative awareness.  		 AFTER 48 HOURS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/02/2014 
Date of Study Completion (India) 03/08/2015 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The primary purpose of study is to monitor the depth of  Anaesthesia using Entropy monitor during Cardiopulmonary bypass on the basis of Numerical Indices provided by Entropy Monitor (Response Entropy {RE} and 
State Entropy {SE}, Burst Suppression Ratio {BSR}  and using Modified Version of Brice Questionnaire after 48 hrs of Surgery about any memories or recall of Intraoperative awareness. Awareness under anaesthesia is terrifying both to the patients and anesthesiologist,its incidence increases all the more during cardiac surgery. Also, during Cardiac Surgery, hemodynamic signs are less reliable guides to anaesthetic depth, as most patients are heavily treated with beta-blocking drugs and antihypertensive medication. Determining anaesthetic depth during Cardio pulmonary bypass (CPB) with variable degree of hypothermia and increased volume of distribution presents an even more complex situation.

In our study,after skin incision mean RE and SE were found to decrease significantly till peak hypothermia. After start of rewarming, mean RE and SE were found to increase significantly till skin closure. We did not find any awareness in all 100 studied subjects, leading to the conclusion that anesthesia technique used for CPB is optimal.
 
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