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CTRI Number  CTRI/2023/04/051871 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 21/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Erector spinae plane block on Inhalation agent consumed during entropy guided general anaesthesia in patients undergoing laparoscopic cholecystectomy surgeries. 
Scientific Title of Study   “Effect of Erector spinae plane block on inhalation agent consumption for Entropy guided general anaesthesia in Laparoscopic Cholecystectomy surgeries.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR GANGISETTY SRI MADHURI 
Designation  Post Graduate 
Affiliation  Dr. B. R. Ambedkar medical College and hospital 
Address  OT COMPLEX, 1ST FLOOR, DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE

Bangalore
KARNATAKA
560045
India 
Phone  7337402887  
Fax    
Email  srimadhuri.g@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MERIN VARGHESE  
Designation  ASSISTANT PROFESSOR  
Affiliation  Dr. B. R. Ambedkar medical College and hospital 
Address  OT COMPLEX, 1ST FLOOR, DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE

Bangalore
KARNATAKA
560045
India 
Phone  8547502337  
Fax    
Email  merinvv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR MERIN VARGHESE  
Designation  ASSISTANT PROFESSOR  
Affiliation  Dr. B. R. Ambedkar medical College and hospital  
Address  OT COMPLEX, 1ST FLOOR, DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE

Bangalore
KARNATAKA
560045
India 
Phone  8547502337  
Fax    
Email  merinvv@gmail.com  
 
Source of Monetary or Material Support  
Dr. B. R. Ambedkar medical college and hospital  
 
Primary Sponsor  
Name  Dr. Merin Varghese 
Address  OT COMPLEX, 1ST FLOOR, DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE  
Type of Sponsor  Other [Self] 
 
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 Merin Varghese   Dr. B. R. Ambedkar medical College and hospital  OT COMPLEX, 1ST FLOOR, DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE
Bangalore
KARNATAKA 
8547502337

merinvv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee Dr. B. R. Ambedkar medical College and 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 
Intervention  ESP block with Isoflurane  ESP Block with 0.25% Bupivacaine 20ML bilateral, by ultrasound guided landmarks and studying its effects on Isoflurane consumption during intraoperative period. 
Comparator Agent  ESP block with Sevoflurane  ESP Block with 0.25% Bupivacaine 20ML bilateral, by ultrasound guided landmarks and studying its effects on Sevoflurane consumption during intraoperative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients posted for laparoscopic cholecystectomy  
 
ExclusionCriteria 
Details  Pregnancy
Patients on psychoactive medications
History of alcohol or drug abuse  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate intraoperative volume consumption of Sevoflurane and Isoflurane when combined with erector spinae plane block.  Volume of inhalation agent consumed with will assessed at the end of the surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To estimate cost incurred per hour in usage of anaesthetic agents   Intraoperative period 
To estimate peri operative patient opioid consumption   Intraoperative period  
To observe postoperative patient comfort and side effects if any   Patients are assessed for every 2 hours up to 24 hours postoperativly 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   01/05/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Laparoscopic cholecystectomy (LC), which has acquired widespread acceptance, has emerged as the gold standard for the surgical management of symptomatic cholelithiasis. Anaesthesia methods can significantly affect the total cost of surgical procedures.The optimal anaesthetic for surgery must provide a secure intraoperative time, easy recovery, while yet being cost-effective. Sevoflurane and Isoflurane, two inhalational anesthetics, have been shown to be useful as feasible anaesthetics for maintaining anaesthesia , as well as ecofriendly comparative to other inhalational agents. Being anaesthesiologists, we must consider the life cycle of drugs in order to include environmental impacts into clinical decisions.
Sevoflurane as an inhalational anesthetic has less respiratory irritation and more rapid emergence in comparison to isoflurane. Isoflurane is 2-3 times more economical than equipotent concentrations of sevoflurane at equivalent doses; therefore, a therapeutic benefit of sevoflurane over isoflurane must be demonstrated in order to justify the cost of using it, in comparison to isoflurane, which is more affordable in a cost sensitive country like India.
Isoflurane and sevoflurane have similar greenhouse gas (GHG) emission profiles. For both gases, life cycle GHG emissions are dominated by waste anesthetic gas. When O2/air is used, isoflurane has higher associated emissions than sevoflurane, in large part because its GWP100 factor ( Global Warming potential of 100 years horizon) is nearly 4 times as high.
The erector spinae plane block is one of the novel techniques , where a local anaesthetic is injected beneath the erector spinae muscles, into the fascial plane. The bilateral ultrasound guided ESP block leads to effective analgesia and a decreased inhalational agent and post operative opioid consumption in patients undergoing LC.
Even though various methods were tried to reduce inhalational agent usage, there is existing knowledge lacunae on the effect of ESP on various inhalational agents and cost, we aim to evaluate the effect of ESPB on consumption of inhaled agents with entropy guidance for uniform depth of anaesthesia. We will prospectively investigate perioperative anesthetic requirements (intraoperative anesthetics and analgesics) by randomizing adult patients for LC surgeries to either sevoflurane- or isoflurane-based entropy guided anesthesia receiving ESP block. Anesthetic consequences will also be considered - intraoperative hemodynamic response, measure depth of anesthesia and estimate clinically significant value indirectly related to cost.
 
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