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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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