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CTRI Number  CTRI/2024/05/067583 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 05/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of recovery after surgery and intraoperative requirement of inhalational agent in opioid based anaesthesia versus opioid free anaesthesia in patients undergoing laparoscopic surgeries 
Scientific Title of Study   comparison of effect of opioid free anaesthesia versus opioid based anaesthesia on post operative recovery profile and consumption of sevoflurane in patients undergoing laparoscopic surgeries: a randomised controlled trial 
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 E M Chandni 
Designation  Postgraduate resident 
Affiliation  Bangalore medical college and research institute 
Address  Department of anaesthesiology Bangalore medical college and research intitute New tharagupet Bangalore Karnataka pin:560002

Bangalore
KARNATAKA
560002
India 
Phone  9567739558  
Fax    
Email  chandnie95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satish Kumar M N 
Designation  Assistant professor 
Affiliation  Bangalore medical college and research institute 
Address  Department of anaesthesiology Bangalore medical college and research institute KR road Bangalore Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9916207210  
Fax    
Email  drsats007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satish Kumar M N 
Designation  Assistant professor 
Affiliation  Bangalore medical college and research institute 
Address  Department of anaesthesiology Bangalore medical college and research institute KR road Bangalore Karnataka 560002

Bangalore
KARNATAKA
560002
India 
Phone  9916207210  
Fax    
Email  drsats007@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute New tharagupet Bangalore Karnataka India PIN 560002 
 
Primary Sponsor  
Name  Bangalore medical college and research institute 
Address  Bangalore medical college and research institute Krishna rajendra road Kalasipalaya Bangalore Karnataka 560002 
Type of Sponsor  Government medical college 
 
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 E M Chandni  Bangalore medical college and research   Department of anaesthesiology Bangalore medical college and research institute Krishna rajendra road Kalasipalaya Bangalore Karnataka 560002
Bangalore
KARNATAKA 
9567739558

chandnie95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  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  opioid based anaesthesia  Patients will receive opioid based anaesthesia using intravenous bolus dose of injection fentanyl 2mcg/kg body weight. 
Intervention  opioid free anaesthesia  Patients will receive opioid free anaesthesia using intravenous combined ketamine and propofol infusion (total volume of 20cc containing 5mg/cc of ketamine and 5mg/cc of propofol) at the rate of 0.25mg/kg body weight/hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who are willing to give informed consent.
Patients of age 18 to 60 years.
ASA grades 1 and 2.
Patients with BMI 19 to 25
Patients undergoing laparoscopic surgeries
Duration of surgery 90 minutes
 
 
ExclusionCriteria 
Details  Patient refusal.
Patients with history of allergy to egg, soya, opioids.
Patients with severe systemic diseases.
Patient requiring postoperative mechanical ventilation.
Patients with neurologic or psychiatric illness.
Patients with past history of cardiovascular diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Dosage of sevoflurane consumed intraoperatively.
 
PSI values and end tidal sevoflurane concentration will be monitored every 5 minutes for the first 30 minutes followed by every 10 minutes for the next one hour.
 
 
Secondary Outcome  
Outcome  TimePoints 
various scoring systems like vas score, apfel score, modified aldrete score for recovery profile.  various scoring systems like vas score, apfel score, modified aldrete score will be monitored in immediate post operative period and then at 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours post operatively.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   03/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The intraoperative administration of opioids was considered as a foundation of anaesthesia. It is used to stabilize the hemodynamics during anaesthesia. Opioids are met with adverse effects, such as respiratory depression, nausea/ vomiting, constipation, tolerance and hyperalgesia. This in turn results in delayed recovery and prolonged hospital stay.

Opioid-free anesthesia (OFA) have been introduced in order to overcome these adverse effects. In OFA, both central and peripheral pathways, are blocked by drugs acting on sodium channels, G-protein-coupled receptors, and N-methyl-D-aspartic acid (NMDA) receptors, some of which also have anti-inflammatory activity.

Inhalational anaesthetics contributes significantly to healthcare-related greenhouse gas emissions, ozone depletion. Prolonged exposure to inhalational agents have shown risks of health hazards, potential to cause genetic damage and oxidative stress among health care personnel in working environments with poor or inadequate scavenging of inhaled anaesthetics. Anaesthetic drugs account for upto 6% of total pharmacy costs, out of which inhalational agents contributes upto 20%.Monitoring depth of anaesthesia partly helps to deliver appropriate dose of anaesthetic agents and helps to overcome these burdens. One such measure is patient state index (PSI) which measures the effect of anaesthesia and level of consciousness.

Our study aims to compare the effect of opioid based anaesthesia over opioid free anaesthesia in intraoperative awareness, post operative recovery profile, consumption of inhalational agents so as to facilitate early discharge of the patient, cut down the cost of anaesthesia as well as the environmental pollution. 
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