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
|
|
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
|
|
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. |