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CTRI Number  CTRI/2023/08/056869 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 22/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.  
Scientific Title of Study   Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varalika Sharma 
Designation  Junior resident 
Affiliation  Department of Anaesthesiology School of Medical Sciences and Research Sharda University 
Address  Department of Anaesthesiology School of medical sciences and research Sharda University
Knowledge park 3 plot no 32 34 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9760331885  
Fax    
Email  dr.varalikasharma7623@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  UC Verma 
Designation  Proffessor 
Affiliation  Department of Anaesthesiology School of Medical Sciences & Research Sharda University 
Address  Department of Anaesthesiology School of medical sciences and research
Knowledge park 3 plot no 32 34 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  UC Verma 
Designation  Proffessor 
Affiliation  Department of Anaesthesiology School of Medical Sciences & Research Sharda University 
Address  Department of Anaesthesiology School of medical sciences and research
Knowledge park 3 plot no 32 34 Greater Noida

UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,school of medical sciences and research,sharda university 
 
Primary Sponsor  
Name  school of medical sciences and research,sharda university 
Address  Greater Noida, Gautam Budh Nagar-201306 (U.P)  
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 
Druttam chandra verma  School of Medical Sciences and Research  Department of Anaesthesiology, second floor B block Sharda University, School of Medical Sciences and Research,knowledge park 3,plot no 32,33,gautam budh nagar,greater noida
Gautam Buddha Nagar
UTTAR PRADESH 
9968604211

uttam.verma@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, school of medical sciences and research, sharda university, greater noida  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  Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy  Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy 
Comparator Agent  comparision between fentanyl and combination of ketamine and lidocaine  Group F – Patients will receive fentanyl 2mcg/kg IV bolus at the time of induction and normal saline infusion preparation till the end of surgery. Group KL –– Patients will receive Inj. Ketamine 0.3mg/kg IV bolus at the time of induction and Inj. Lidocaine 1.5mg/kg followed by 2mg/kg/hr. IV infusion till the end of surgery. 
Comparator Agent  comparison of fentanyl with combination of ketamine and lidocaine  Group F – Patients will receive fentanyl 2mcg/kg IV bolus at the time of induction and normal saline infusion preparation till the end of surgery. Group KL –– Patients will receive Inj. Ketamine 0.3mg/kg IV bolus at the time of induction and Inj. Lidocaine 1.5mg/kg followed by 2mg/kg/hr. IV infusion till the end of surgery. All the patients will be kept under supervision for 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I and II
2. Age 18-60yrs
3. Both genders
4. Surgeries ≤ 2 hours
 
 
ExclusionCriteria 
Details  1. BMI > 30 kg m¬-2
2. Pregnant females
3. Patients having history of motion sickness and migraine.
4. Patients having history of drug allergy to ketamine and lidocaine.
5. Patients having history of respiratory, cardiovascular, renal, hepatic and endocrine disease and psychosis.









 
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of fentanyl (opioid) versus ketamine & lidocaine (opioid free) anaesthesia on post-operative nausea and vomiting in laparoscopic cholecystectomy.  Post operative 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of fentanyl (opioid) versus ketamine & lidocaine (opioid free) anaesthesia in laparoscopic cholecystectomy with regard to:
1. VAS Score for post-operative pain.
2. Duration of analgesia in post-operative period.
3. Sedation score postoperatively.
4. The duration of discharge from PACU.



 
24 hours 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 
Date of First Enrollment (India)   10/09/2023 
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 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 - NO
Brief Summary  

Opioids are commonly used for analgesia and supplementary sedation during general anaesthesia and are the most widely used agents for the treatment of acute pain in the immediate postoperative period. Opioids provide effective analgesia and stable intraoperative hemodynamics, which are valuable during the perioperative period. However, the use of opioids during the perioperative period is risky. Opioids have many potential adverse effects, including respiratory depression, postoperative nausea and vomiting (PONV), and opioid-induced hyperalgesia (OIH). These complications are associated with delayed patient recovery, prolonged stay in the post-anaesthetic care unit (PACU), delayed hospital discharge, and unexpected hospitalization, all contributing to an increased burden on patients and resources.Perioperative opioids are administered for postoperative analgesia, and intra-operatively to control the sympathetic response to surgical stimuli, frequently as a surrogate for presumed pain.Opioid free anaesthesia (OFA) is a technique where the intraoperative use of systemic, neuraxial or intracavitary opioid is completely avoided. This new technique can provide intraoperative hemodynamic stability, immobility and postoperative analgesia without administering opioid drugs, and therefore the absence of the numerous side effects caused by opioids.3Opioids are used in general anaesthesia in various surgeries, though laparoscopic surgeries are considered relatively less painful and are associated with early recovery and lesser duration of hospital stay, they can cause severe pain, especially in four hours of the immediate post-operative period. This may be attributed to the peritoneal irritation caused by the carbon dioxide insufflation pressures, bowel handling by the surgeons or irritation caused by the residual or retained blood.4  Post-operative nausea and vomiting (PONV) are some of the most common complications after anaesthesia, often reducing patient satisfaction and prolonging the recovery and discharge from hospital. This is defined as nausea or vomiting that occurs during first 24 hours to 48 hours after surgery. Opioids can cause nausea and vomiting by stimulating the area postrema at floor of fourth ventricle.5The risk of PONV in the general surgical population is approximately 30%. In high-risk patient groups, or high-risk surgical procedures, the risk of PONV can be as high as 80%. PONV is a distressing experience for the patient and can have a significant impact on patient satisfaction. PONV may prolong post-anaesthesia care unit (PACU) stay and increase the risk of postoperative complications.6Lidocaine is an amide local anaesthetic that has analgesic, antihyperalgesic and anti-inflammatory properties. These properties of lidocaine are mediated by channel blockade, inhibition of G protein coupled receptors and NMDA receptors.7In addition to improving analgesia, perioperative lidocaine infusion shortens the duration of postoperative ileus by an average of 8 hours, and decreases the incidence of postoperative nausea and vomiting.Ketamine, a phencyclidine derivative, an N-methyl-d-aspartate antagonist, blunts central pain sensitization at sub anaesthetic doses (0.3mg/kg or less). Ketamine has been increasingly used as an adjunct in the management of acute postoperative pain. Ketamine can inhibit the spread of nociceptive impulses to the brain. It can be administered by multiple routes, including intravenous, bolus injection, continuous IV infusion, epidural route and even wound infiltration. Ketamine is now preferred drug in many procedures like sedation for MRI, premedication in children, procedural sedation and acute and chronic pain management. Sub anaesthetic ketamine improves pain scores and reduces perioperative opioid consumption in a broad range of surgical procedures with a minimal risk of side effects.Lacunae in the existing knowledgeExtensive search of literature reveals that, it has been found that no previous studies have        observed the effect of ketamine and lidocaine (OFA) on post-operative nausea and vomiting. Therefore, in this study we will compare the effect of fentanyl (opioid) versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

 

 
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