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CTRI Number  CTRI/2025/07/091974 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of intraoperative antinociception efficacy with opioid vs opioid free anaesthesia. 
Scientific Title of Study   Comparative evaluation of Intraoperative antinociception efficacy with opioid (Fentanyl) vs opioid free anaesthesia (ketorolac, dexmedetomidine and ketamine) in patients undergoing Laparsocopic 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  Dr Sameera Khan 
Designation  PG 1ST Year Resident Doctor 
Affiliation  School of Medical Sciences and Research, Sharda University 
Address  Department of Anaesthesiology School of Medical Sciences and Research,Sharda University,plot no 32, knowledge park 3 ,Greater Noida ,Gautam Buddha Nagar, UTTAR PRADESH, INDIA

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9560485736  
Fax  0120-2323712  
Email  sameera.khan@sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uttam Chandra Verma 
Designation  Head of Department 
Affiliation  School of Medical Sciences and Research, Sharda University 
Address  School of Medical Sciences and Research,Sharda University, plot no 32 , knowledge park 3,Greater Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Uttam Chandra Verma 
Designation  Head of Department 
Affiliation  School of Medical Sciences and Research, Sharda University 
Address  School of Medical Sciences and Research,Sharda University, plot no 32 , knowledge park 3,Greater Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9968604211  
Fax    
Email  uttam.verma@sharda.ac.in  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Sharda Hospital ,Sharda University, Knowledge park 3 , Greater Noida 
 
Primary Sponsor  
Name  SHARDA HOSPITAL 
Address  Department of Anaesthesia,Sharda Hospital,School of Medical Sciences and Research, Sharda University, Knowledge Park 3, Greater Noida 
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 
Sameera Khan  Department of Anaesthesia ,Sharda Hospital  School of Medical Sciences and Research,Sharda University,Knowledge Park 3 Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH 
09560485736

sameera.khan@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparative evaluation of antinociception efficacy of opioid vs opioid free anaesthesia  Comparison of opioid (fentanyl) vs opioid free anaesthesia (ketamine, dexmedetomidine, ketorolac) in patients undergoing Laparoscopic Cholecystectomy 
Comparator Agent  Patients of group F will receive an iv bolus of inj fentanyl 2 mcg/kg.After 10 min infusion of fentanyl started at rate of 1 mcg//kg/hr.Patients of group KDK will receive an iv bolus of inj ketorolac 30 mg iv , inj ketamine 0..3 mg/kg, inj dexmedetomidine 0.5 mcg/kg.  Patients of group F will receive an iv bolus of inj Fentanyl 2mcg/kg. After 10 min infusion of fentanyl started at rate of 1mcg/kg/hr.A repeat dose of inj Fentanyl 10 mcg iv bolus will be given if SPI exceeds 50. Patients of group KDK will receive an iv bolus of inj ketorolac 30 mg iv, inj ketamine 0.3 mg/kg, inj dexmedetomidine 0.5 mcg/kg.A repeat dose of inj ketamine 0.2 mg/kg iv bolus will be administered if the SPI exceeds 50.Infusion of dexmedetomidine 0.2 mcg/kg will be continued till the end of skin closure. Both the groups will be induced with inj propofol at 2mg/kg iv bolus and cis atracurium 0.2 g/kg to facilitate intubation followed by continuous infusion of inj propofol at 10 mg/kg/hr for first 10 min , 8mg/kg/hr for next 10 min , and 6 mg //kg/hr subsequently to maintain SE/RE in the range of 40-60 till the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient scheduled for Laparoscopic cholecystectomy
2.Age 18-60 years
3.ASA grade 1 and 2
4.Both genders
5.Duration of surgery less than 2 hours  
 
ExclusionCriteria 
Details  BMI more than 30 kg per meter square
History of CNS, vascular, renal and respiratory diseases
History of endocrine disease-diabetes mellitus and thyroid disease
History of psychiatric illness
Pregnant females
History of usage of opioids and any other analgesics
Patient having history of drug allergy to ketamine, ketorolac and
dexmedetomidine
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the intraoperative anti nociception efficacy with opioid vs opioid free anaethesia (ketamine, dexmedetomidine, ketorolac) by change in SPI in response to surgical noxious stimulation following skin incision  24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: -
a) SPI
b) HR, MAP, Lacrimation, sweating
 
24 hrs 
2) To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) Duration of Postoperative analgesia and pain severity
b)Duration of Postoperative Nausea and Vomiting
c)Duration of discharge from Post Anaesthetic Care Unit
d)Post operative assessment of awareness
e)Total consumption of propofol, fentanyl, cis-atracurium, ketamine, Dexmedetomidine and Ketorolac.
 
24 hrs 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   10/08/2025 
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  

Nociception refers to the unconscious detection of a noxious stimulus caused by trauma or surgical intervention, which is manifested through responses of the autonomic nervous system. Providing anti-nociception is one of the primary functions of general anaesthesia during surgical procedure.

Opioid-Free Anaesthesia (OFA) is a developing technique and a growing focus in recent research, founded on the concept that eliminating intraoperative opioid use may lead to improved postoperative outcomes.  

Opioid-free anaesthesia refers to the complete avoidance of opioids during the preoperative, intraoperative, and recovery phases. Despite their continued role as a key component in general anaesthesia for managing pain during and after surgery, opioids are linked to a range of side effects including drowsiness, dizziness, constipation, nausea, vomiting, respiratory depression, pruritus, and urinary retention. Additionally, two significant concerns associated with opioid use are the development of hyperalgesia and opioid tolerance. 

Therefore, it is important to investigate and assess novel non-opioid analgesic agents following laparoscopic cholecystectomy as part of strategies aimed at reducing opioid use. Dexmedetomidine, a centrally acting alpha-2 adrenoreceptor agonist, shows considerable promise in enhancing analgesia and stabilizing hemodynamic responses during endotracheal intubation and the creation of pneumoperitoneum. Its perioperative analgesic effectiveness and sedative qualities have been extensively explored across various major surgical procedures, yielding encouraging outcomes. Dexmedetomidine’s potential role in facilitating early recovery following day care surgeries has recently become a topic of growing interest among anesthesiologists. Ketamine possesses strong analgesic, amnesic, and opioid-sparing characteristics. When administered in low doses (less than 0.5 mg/kg), it provides effective analgesia with minimal adverse effects. A single administration of ketamine can markedly decrease postoperative opioid requirements in day care procedures like laparoscopic cholecystectomy.  

The Surgical Pleth Index (SPI) serves as an objective measure to assess the balance between nociception and anti-nociception, helping to guide intraoperative analgesic administration. SPI values range from 0 to 100, with a recommended target range of 20 to 50 during general anesthesia. An SPI value exceeding 50 for more than 3 to 5 minutes typically indicates excessive noxious stimulation, suggesting the need for additional analgesic intervention.  

Entropy monitoring is an objective method consisting of two components—Response Entropy (RE) and State Entropy (SE)—which reflect the levels of analgesia and hypnosis during general anesthesia.  

Ketorolac is a nonsteroidal anti-inflammatory drug that possesses significant analgesic potency. It provides analgesia equivalent to commonly used doses of meperidine and morphine. It has been used extensively in emergency departments for a variety of painful conditions, frequently as a first-line drug.


 
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