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CTRI Number  CTRI/2026/01/101899 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF THE EFFECT OF PERIOPERATIVE INTRAVENOUS INFUSION OF DEXMEDETOMIDINE AND LIGNOCAINE VERSUS FENTANYL ON INTRAOPERATIVE HAEMODYNAMICS AND POSTOPERATIVE ANALGESIA IN ELECTIVE LAPAROSCOPIC SURGERY 
Scientific Title of Study   COMPARISON OF THE EFFECT OF PERIOPERATIVE INTRAVENOUS INFUSION OF DEXMEDETOMIDINE AND LIGNOCAINE VERSUS FENTANYL ON INTRAOPERATIVE HAEMODYNAMICS AND POSTOPERATIVE ANALGESIA IN ELECTIVE LAPAROSCOPIC SURGERY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Wg Cdr Dr Bhaskar Das 
Designation  Classified specialist Anaesthesia 
Affiliation  7 Air Force Hospital 
Address  7 Air Force Hospital,Gale road, Kanpur Cantt Kanpur Nagar

Kanpur Nagar
UTTAR PRADESH
208001
India 
Phone  7507088990  
Fax    
Email  drbhaskar23@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Wg Cdr Dr Bhaskar Das 
Designation  Classified specialist Anaesthesia 
Affiliation  7 Air Force Hospital 
Address  7 Air Force Hospital,Gale road, Kanpur Cantt Kanpur Nagar

Kanpur Nagar
UTTAR PRADESH
208001
India 
Phone  7507088990  
Fax    
Email  drbhaskar23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shaik Nagoor Vali 
Designation  Junior Resident Anaesthesiology 
Affiliation  7 Air Force Hospital 
Address  7 Air Force Hospital,Gale road, Kanpur Cantt Kanpur Nagar
7 Air Force Hospital,Gale road, Kanpur Cantt Kanpur Nagar
Kanpur Nagar
UTTAR PRADESH
208001
India 
Phone  8008212019  
Fax    
Email  Nagurvali7@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Air Force Hospital 
Address  7 Air Force Hospital Gale road Kanpur Cantt Kanpur Nagar 
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 
Wg Cdr Bhaskar Das  7 Air Force Hospital  7 Air Force Hospital,Gale road, Kanpur Cantt
Kanpur Nagar
UTTAR PRADESH 
7507088990

drbhaskar23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
7 Air Force Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K839||Disease of biliary tract, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  65.00 Day(s)
Gender  Both 
Details  Adults age 18–65 years.
ASA physical status I–II (or III if you prefer).
Scheduled for elective laparoscopic procedures under general anesthesia with expected duration 60–180 minutes.
Able to provide informed consent.
 
 
ExclusionCriteria 
Details  Known allergy to study drugs (dexmedetomidine, lignocaine, fentanyl).
Severe cardiac conduction disease (2nd or 3rd degree heart block without pacemaker).
Significant hepatic dysfunction, severe renal impairment.
Pregnancy or breastfeeding.
Chronic opioid use or chronic pain requiring opioids.
BMI more than 35
Severe psychiatric disease or inability to report pain scores.
Seizure disorder relative contraindication to lignocaine infusion 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare intraoperative haemodynamic effect between Dexmedetomidine and Lignocaine group with Fentanyl group during elective laparoscopic surgeries and postoperative analgesia in both the groups. Further to achieve the goal of opioid free anaesthesia  To compare intraoperative haemodynamic effect between Dexmedetomidine and Lignocaine group with Fentanyl group during elective laparoscopic surgeries and postoperative analgesia in both the groups. Further to achieve the goal of opioid free anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
Compare postoperative pain scores (VAS/NRS) at rest at 0, 1, 2, 6, 12, 24 hours.

Total postoperative opioid consumption in the first 24 hours.

Time to first analgesic request.

Incidence of PONV, sedation scores, respiratory depression, and other adverse events.

Time to extubation / PACU stay length and overall recovery profile (where applicable).
 
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   09/02/2026 
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 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  

Laparoscopic surgeries are becoming popular due to several postoperative benefits allowing quicker recovery, less tissue damage, avoiding big surgical incision, shorter hospital stay with consequent reduction in health care cost. But anaesthetic management in these patients has become complicated due to cardiopulmonary changes occurring during creation of pneumoperitoneum with CO2 and patient position required for different laparoscopic surgeries. 

Laryngoscopy, tracheal intubation and pneumoperitoneum are associated with sympathetically mediated adverse haemodynamic effect like elevation of arterial pressure, heart rate and decrease in cardiac output which adversely affect the outcome. Dexmedetomidine is selective alpha 2 adrenoceptor agonist. It has central sympatholytic action which helps in providing haemodynamic stability. It also has both analgesic and anaesthetic sparing property and Lignocaine is local anaesthetic has proven effect on attenuating stress response during intubation and extubation, also provides analgesia. Hence, this study was designed to evaluate the effect of Dexmedetomidine and Lignocaine in patient hemodynamics, postoperative analgesia in comparison to fentanyl during laparoscopic cholecystectomy. 

 
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