| CTRI Number |
CTRI/2026/03/105501 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which Medicine Controls Pain Better After Keyhole Surgery: Dexmedetomidine or Lidocaine? |
|
Scientific Title of Study
|
Comparison Of The Effect of Intravenous Infusion of Dexmedetomidine And Lidocaine Intraoperatively On Postoperative Analgesia In Patients Undergoing Laparoscopic surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Shailesh Meswani |
| Designation |
Junior Resident |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, fifth floor, Hitech building, Dr. D.Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9773998668 |
| Fax |
|
| Email |
shivanimeswani98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, fifth floor, Hitech building, Dr. D.Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422710943 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Bagle |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Dr. D.Y. Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia, fifth floor, Hitech building, Dr. D.Y Patil Medical College, Hospital and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9422710943 |
| Fax |
|
| Email |
draparnabagle@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, fifth floor, Hitech building, Dr. D.Y Patil Medical College and Hospital and Research Centre, Pimpri, Pune, Maharashtra, India, pin code- 411018 |
|
|
Primary Sponsor
|
| Name |
Shivani Meswani |
| Address |
Department of Anesthesia, fifth floor, Hitech building, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Shivani Meswani |
Dr. D.Y Patil Medical College hospital and research centre |
Department of Anesthesia, fifth floor, Hitech building, Dr. D.Y Patil Medical college, Hospital and Research Centre, Pimpri. Pune
Pune
MAHARASHTRA |
9773998668
shivanimeswani98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub- Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K36||Other appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine infusion in group D |
Patients will receive a loading dose of dexmedetomidine 0.5 micrograms per kilogram intravenously over 10 minutes followed by a maintenance infusion of of 0.5 microgram per kilogram per hour until the end of surgery |
| Intervention |
Lidocaine infusion in group L |
Patients will receive a loading dose of lidocaine 1.5 milligrams per kilogram over ten minutes followed by 2 milligram per kilogram per hour until the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA grade 1 and 2
Patients scheduled for elective laparoscopic surgeries surgeries under general anesthesia
Patients with no known allergy or contraindication to dexmedetomidine lidocaine or other study medications |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity or allergy to dexmedetomidine lidocaine or any other component of the study drugs
ASA grade 3 or above
Severe hepatic renal or cardiovascular dysfunction
History of arrhythmias conduction abnormalities or on antiarrhythmic medications
Pregnant or lactating women
History of chronic pain opioid use or regular analgesic intake within the past 48 hours
Patients with neurological or psychiatric disorders that may interfere with pain perception or assessment
Body mass index more than 35
Intraoperative conversion from laparoscopic to open surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the effect of intravenous infusion of dexmedetomidine and lidocaine on postoperative analgesia in patients undergoing laparoscopic surgeries |
Rescue analgesia at 30 min, 1 hour, 2 hours, 8 hours, 16 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="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
|
This study is a prospective randomized single blind comparative clinical study conducted at the Department of Anesthesiology at Dr DY Patil Medical College and Hospital Pune 1-2.pdf None The aim of the study is to compare the effect of intravenous infusion of dexmedetomidine and lidocaine given during surgery on postoperative pain relief in patients undergoing elective laparoscopic surgeries A total of 66 patients aged 18 to 60 years with ASA grade I or II will be included and divided into two groups of 33 each. One group will receive dexmedetomidine infusion and the other group will receive lidocaine infusion during surgery The study will assess postoperative pain scores time to first rescue analgesia total analgesic consumption in 24 hours intraoperative heart rate and blood pressure opioid requirement sedation levels and any side effects All patients will receive standard general anesthesia. Pain will be assessed using the Visual Analog Scale and sedation will be assessed using the Ramsay Sedation Score. Statistical analysis will be done using appropriate tests The objective is to determine which drug provides better postoperative analgesia with stable hemodynamics and fewer side effects in laparoscopic surgeries |