CTRI Number |
CTRI/2024/04/064953 [Registered on: 01/04/2024] Trial Registered Prospectively |
Last Modified On: |
05/10/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison study between perioperative lidocaine and dexmedetomidine infusion for postoperative pain in laparoscopic cholecystectomy patients |
Scientific Title of Study
|
Comparison of effect of perioperative infusion of lidocaine vs dexmedetomidine on post operative pain 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 |
Anam Rizwan |
Designation |
Junior Resident |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Anesthesia 1st floor Eras Lucknow Medical College and Hospital Lucknow UP
Lucknow UTTAR PRADESH 226003 India |
Phone |
9651460884 |
Fax |
|
Email |
rizwan.anam05@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Shirin Parveen |
Designation |
Professor |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Anesthesia 1st floor Eras Lucknow medical College and Hospital Lucknow UP
Lucknow UTTAR PRADESH 226003 India |
Phone |
7388732089 |
Fax |
|
Email |
shirin_grmc@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Anam Rizwan |
Designation |
Junior Resident |
Affiliation |
Eras Lucknow Medical College and Hospital |
Address |
Department of Anesthesia 1st floor Eras Lucknow Medical College and Hospital Lucknow UP
Lucknow UTTAR PRADESH 226003 India |
Phone |
9651460884 |
Fax |
|
Email |
rizwan.anam05@gmail.com |
|
Source of Monetary or Material Support
|
Eras Lucknow Medical College and Hospital |
|
Primary Sponsor
|
Name |
Eras Lucknow Medical College and Hospital |
Address |
Department Of Anesthesia 1st floor Eras Lucknow Medical College and Hospital Lucknow UP |
Type of Sponsor |
Private 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 |
Dr Shirin Parveen |
Eras Lucknow Medical College and Hospital |
OT COMPLEX AND PACU Eras Lucknow Medical College and Hospital Sarfarazganj Hardoi Road Lucknow 226003 Lucknow UTTAR PRADESH |
7388732089
shirin_grmc@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Comittee of Eras Lucknow Medical College & Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
DEXMEDETOMIDINE |
IV INFUSION LOADING DOSE OF 1MCG/KG AND MAINTAINENCE DOSE OF 0.4MCG/KG/HR TILL END OF SURGERY |
Intervention |
LIDOCAINE |
IV INFUSION LOADING DOSE OF 1.5MG/KG AND MAINTAINENCE DOSE OF 2MG/KG/HR TILL END OF SURGERY |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients undergoing Laparoscopic Cholecystectomy under General Anesthesia.
Age between 18 – 60 years
ASA Grade I and II
|
|
ExclusionCriteria |
Details |
BMI >30kg/m2.
Pregnant and Lactating mothers
Patients having sinus bradycardia or heart blocks,
Patients On steroids.
History of Allergy to study drugs
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
The Efficacy of Intravenous Lidocaine or Intravenous Dexmedetomidine for post operative pain relief following laparoscopic cystectomy would be determined by this study |
Surgery of max 1hr15mins and followed up for 12hours postoperative period. |
|
Secondary Outcome
|
Outcome |
TimePoints |
The Efficacy of Intravenous Lidocaine or Intravenous Dexmedetomidine for Recovery profile & time to first rescue analgesic following laparoscopic cystectomy would be determined by this study |
Surgery of max 1hr15mins & followed up for 12hours postoperative period |
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
10/04/2024 |
Date of Study Completion (India) |
15/07/2024 |
Date of First Enrollment (Global) |
10/04/2024 |
Date of Study Completion (Global) |
15/07/2024 |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The Efficacy of Intravenous Lidocaine or Intravenous Dexmedetomidine for post operative pain relief following laparoscopic cystectomy would be determined by this study. Dexmedetomidine offers significant advantages
over lidocaine in terms of postoperative pain control and reduced analgesic
requirements
Post-operative
sedation scores and recovery profile were generally comparable between the two
groups. On the basis of these findings, it could be inferred that perioperative
infusion of both lidocaine as well as dexmedetomidine was effective in delaying
the post-operative rescue analgesic need with almost similar recovery profile.
However, of the two dexmedetomidine had a slight edge over lidocaine both in
terms of analgesic effect as well as recovery profile. |