| 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
|
|
|
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
|
|
|
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
|
|
|
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. |