| 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
|
|
|
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
|
|
|
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. |