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CTRI Number  CTRI/2023/12/060681 [Registered on: 22/12/2023] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to study the effect of two regimen, opioid and opioid free anaesthesia regimen in patients undergoing laparoscopic surgeries. 
Scientific Title of Study   A Randomized controlled trial to compare the postoperative analgesia and haemodynamic response between Opioid Free Anaesthesia regimen(OFA) and standard opioid anaesthesia technique among patients undergoing laparoscopic non cardiac surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrBlesita T Jose 
Designation  post graduate student 
Affiliation  Department of Anaesthesiology, Believers church medical college hospital thiruvalla 
Address  Thrikkukaran house varakkara varandarappilly p o
1 BHK, Room No: GF00A Believers church medical college hospital Thiruvalla Pathanamthitta kerala
Pathanamthitta
KERALA
680303
India 
Phone  8943186007  
Fax    
Email  blesitatjose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ASHU SARA MATHAI 
Designation  HOD, DEPARTMENT OF ANAESTHESIA 
Affiliation  HOD, DEPARTMENT OF ANAESTHESIOLOGY 
Address  HOD DEPARTMENT OF ANAESTHESIOLOGY BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL THIRUVALLA
HOD DEPARTMENT OF ANAESTHESIOLOGY BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL THIRUVALLA
Pathanamthitta
KERALA
689103
India 
Phone  9888500240  
Fax    
Email  hod.anaesthesiology@bcmch.edu.in  
 
Details of Contact Person
Public Query  
Name  DrBlesita T Jose 
Designation  post graduate student 
Affiliation  Department of Anaesthesiology, Believers church medical college hospital thiruvalla 
Address  Thrikkukaran house varakkara varandarappilly p o
1 BHK, Room No: GF00A Believers church medical college hospital Thiruvalla Pathanamthitta kerala
Pathanamthitta
KERALA
680303
India 
Phone  8943186007  
Fax    
Email  blesitatjose@gmail.com  
 
Source of Monetary or Material Support  
Believers church medical college hospital THiruvalla 
 
Primary Sponsor  
Name  DrAshu Sara Mathai 
Address  HOD Department of anaesthesiology Believers Church Medical College Hospital Thiruvalla 
Type of Sponsor  Other [Guide] 
 
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 Blesita T jose  Believers church medical college hospital Thiruvalla  Operation Theatre complex Department of Anaestheia Believers church medical college hospital Thiruvalla
Pathanamthitta
KERALA 		 8943186007

blesitatjose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE BELIEVERS CHURCH MEDICAL COLLEGE HOSPITAL THIRUVALLA  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  DEXMEDETOMIDINE + KETAMINE + LIGNOCAINE SOLUTION  a premixed solution of 50 mcg dexmedetomidine, 50 mg ketamine and 500 mg intravenous lignocaine with 0.9% normal saline to constitute a volume of 50 cc will be prepared. 10 ml of this solution will be drawn in a separate syringe for the bolus dose. The remaining 40 cc solution will be used for maintenance dosing.Bolus dose will be given before induction and maintanance dose will be given throughout the surgery @ 1ml/10kg  
Comparator Agent  OPIOID (FENTANYL)  a 10 cc syringe containing 10 ml of 2 mcg/kg fentanyl injection as bolus dose and a 50 cc syringe with 40 ml of 0.9% normal saline solution will be prepared for maintenance dosing. A top up dose of 25mcg of fentanyl will be given each hour if the surgery prolongs more than 2 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American society of anaesthesiologist (ASA) classification I,II,III
Patients undergoing elective, laparoscopic, non cardiac surgeries of less than 4 hours
duration 
 
ExclusionCriteria 
Details  Patients who refuse consent/lack the capacity to give consent
Patient with known allergy to the study drugs used
Patient with co-existing liver or renal disease
Patients undergoing conversion to open surgical technique
Patients with preoperative uncontrolled hypertension (Preoperative BP>190/110 mmhg) or
hypotension (MAP<65 mmhg)
Pregnancy
Patients with Seizure disorder
Patients with psychiatric illnesses or on antipsychotic medications
Patients with Cardiac arrhythmias /AV block/ Bradycardia (<50/min) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intraoperative haemodynamic stability (heart rate,blood pressure)
post operative analgesia using Numerical Rating Score 		 Intraoperative haemodynamic stability (heart rate,blood pressure)
at 0,3,6,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Ramsay sedation score  24hours 
gastrointestinal recovery after surgery,haemodynamic instability,postoperative nausea and vomiting, respiratory depression,pruritus   24hours 
quality of Recovery-15  24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/01/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [blesitatjose@gmail.com].

  6. For how long will this data be available start date provided 01-01-2024 and end date provided 01-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is Randomized controlled single centre trial to compare the intraoperative haemodynamic stability, Postoperative analgesia and post operative adverse effects in terms of nausea and vomiting, sedation, respiratory depression, pruritis, ileus, heamodynamic instability of an opioid free anaesthesia regimen versus standard opioid based anaesthesia regimen in patients undergoing non cardiac laparoscopic surgeries. 
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