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CTRI Number  CTRI/2021/12/038697 [Registered on: 16/12/2021] Trial Registered Prospectively
Last Modified On: 14/12/2021
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   Is opioid free anaesthesia better than opioid anaesthesia for post operative recovery? 
Scientific Title of Study   Effect of opioid free and opioid anaesthesia on postoperative recovery in patients undergoing laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Chauhan 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology and Intensive Care, B.L.Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  8377936347  
Fax    
Email  anesthesia.geeta.2020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anju R Bhalotra 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology and Intensive Care, B.L.Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Anju R Bhalotra 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology and Intensive Care, B.L.Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9968604219  
Fax    
Email  drakgk@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Intensive Care 
Address  Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 
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 Geeta Chauhan  Lok Nayak Hospital  Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI 		 8377936347

anesthesia.geeta.2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Opioid Anaesthesia  Standard opioid anaesthesia using intravenous dexamethasone 0.1 mg/kg and intravenous fentanyl 2 mcg/kg over 10 mins followed by an infusion of 0.5 mcg/kg/hr. 
Intervention  Opioid Free Anaesthesia  Opioid free anaesthesia using intravenous dexamethasone 0.1 mg/kg, loading dose of dexmedetomidine 0.5 mcg/kg over 10 mins followed by an infusion of 0.5 mcg/kg/hr, loading dose of lignocaine 1.5 mg/kg followed by an infusion of 1.5 mg/kg/hr and ketamine 0.25 mg/kg bolus. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) Physical Status Grade I-II 
 
ExclusionCriteria 
Details  1.Patients with AV block or severe bradycardia
2.Patients having BMI >30 kg/m2
3.Patients with allergy to any of the study drugs
4.Patients with cardiac, renal, hepatic and psychiatric illness.
5.H/o chronic use of opioid analgesic/ chronic steroids/ NSAIDS/ or any chronic drug therapy
6.H/o alcohol abuse
7.Patients who are pregnant or are breastfeeding
8.Patients with decreased autonomic control- elderly, diabetic, chronic hypertension, severe cardiac disease, on drugs like beta blockers or calcium channel blockers
9.Patient refusal
 
 
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 
Difference in postoperative recovery using QoR-40 score 24 hours after surgery.  24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative VAS scores

 		 at 15 min, 30 min, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, and 24 hr postoperatively.  
Requirement of postoperative analgesics in the first 24 hours after surgery  over first 24 hours after surgery 
Any intraoperative bradycardia, hypotension, tachycardia, or hypertension  at any point of time intraoperatively 
Sedation score in PACU  on arrival at Post Aanaesthesia Care Unit (PACU) 
Time for readiness for discharge from PACU (PADSS score)  0 min, 15 mins, 30 mins, 45 mins, 60 mins, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours in PACU 
Postoperative opioid related side effects  within 24 hours of postoperative period 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   29/12/2021 
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 Applicable 
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   Opioid free anaesthesia is an anaesthetic technique where opioids are not used in the intraoperative period, by either systemic, neuraxial or intracavitary route. By avoiding the use of opioids in the perioperative period, the number of opioid related side effects are reduced.
Recently, multimodal analgesia techniques are becoming the basis of successful fast track surgery. These multidrug regimens aim at decreasing postoperative pain and intraoperative and postoperative opioid related adverse effects, thus hastening recovery. A multimodal approach allows reduction of the dose of each individual  drug and exploits the synergistic effect among drugs, thereby reducing their side effect.
Thus, we decided to compare the effect of opioid free and opioid anaesthesia on postoperative recovery in patients undergoing laparoscopic cholecystectomy.
 
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