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CTRI Number  CTRI/2023/11/059905 [Registered on: 16/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparison between two different drugs in laproscopic surgery under general anesthesia  
Scientific Title of Study   Comparison between opioid free Anesthesia and opioid based anaesthesia for patients undergoing laparoscopic surgeries under general anaesthesia. A double blinded randomized control 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 CHHAYA JOSHI 
Designation  Professor of anaesthesiology  
Affiliation  S.Nijalingappa Medical College and HSK Hospital, Navanagar, Bagalkot.  
Address  E 59 sector no 32 Navanagar Bagalkot

Bagalkot
KARNATAKA
587103
India 
Phone  9743320105  
Fax    
Email  drchhayajoshi1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRDARSHINI T K 
Designation  1st year Anaesthesia Postgraduate  
Affiliation  S.Nijalingappa Medical College and HSK Hospital, Navanagar, Bagalkot.  
Address  Department of anaesthesia S.Nijalingappa medical college Navanagar, Bagalkot.

Bagalkot
KARNATAKA
587103
India 
Phone  7411674099  
Fax    
Email  darshinikrishnamurthy@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRDARSHINI T K 
Designation  1st year Anaesthesia Postgraduate  
Affiliation  S.Nijalingappa Medical College and HSK Hospital, Navanagar, Bagalkot.  
Address  Department of anaesthesia S.Nijalingappa medical college Navanagar, Bagalkot.

Bagalkot
KARNATAKA
587103
India 
Phone  7411674099  
Fax    
Email  darshinikrishnamurthy@gmail.com  
 
Source of Monetary or Material Support  
S NIJALINGAPPA MEDICAL COLLEGE , BAGALKOT 
 
Primary Sponsor  
Name  S Nijalingappa Medical College and HSK Hospital. 
Address  1st floor, Major OT complex,S Nijalingappa Medical college and HSK hospital Bagalkot 
Type of Sponsor  Private 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 Chhaya Joshi  S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL Bagalkot  First floor Major ot
Bagalkot
KARNATAKA 		 9743320105

drchhayajoshi1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl and normal saline infusion   Fentanyl infusion (50 mcg in 50 ml NS at the rate of 1mcg/kg/hr ) and normal saline infusion at the rate of 5ml/hr will be started and continued through out the procedure 
Intervention  Lidocaine and dexmedetomidine infusion  Inj lidocaine infusion 1.5 mg/ kg bolus (diluted to 5 ml with NS ) and dexmedetomidine 0.6 mcg/kg bolus (diluted to 5 ml NS ) will be given to patients undergoing laparoscopic surgeries through out the procedure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA physical status 1 and 2
2.Age between 18 to 65 years
3.Patients undergoing laparoscopic surgeries under general anaesthesia  
 
ExclusionCriteria 
Details  1.History of opioid use 1 month prior to surgery
2.chronic opioid addiction
3.Inability to comprehend visual analogue scale
4.history of significant hepatic renal and cardiac disease
5.history of chronic pain and drug abuse  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the heart rate and mean arterial pressure intraoperative with continuous lidocaine and dexmedetomidine infusion as opposed to conventional opioid based anaesthesia   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.postoperative pain in first 24 hours and time to rescue analgesia is compared in both groups
2.postoperative nausea vomiting assessment in both groups
3.sedation scoring in one after extubation will be assessed in both groups using Ramsay sedation scoring  		 24 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/12/2023 
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="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   Opioid free anaesthesia is the use of multimodal or balanced analgesia,the principle is to gain additive analgesic effects from different drugs while minimising side effects, particularly those of opioids.studies have shown that opioid free anaesthesia fast tracks surgery,reduces hospital stay, early mobilization and enteral nutrition.
The current study is planned to compare the analgesic and sedative effects of opioids (fentanyl) with opioid free drugs (lidocaine and dexmedetomidine)during perioperative period and to compare recovery characteristics and hemodynamics (heart rate and mean arterial pressure)as secondary outcome.
Inorder to provide adequate perioperative pain management the over use and over prescription of opioids have contributed to opioid crisis. Reports indicate that the number of overdose deaths from prescription and illicit opioids have quadrupled since 2000 from opioid addiction.
Improper opioid use , unsecure opioid storage and lack of appropriate disposal of unused or expired opioids increase the availability of these drugs for others to abuse and are major contributors to current opioid crisis . To overcome this FDA and department of justice drug enforcement administration have uniform guidelines regarding using ,storing and not sharing with others.FDA recommend that opioids are best disposed via medicine take back programs.

 
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