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CTRI Number  CTRI/2022/01/039789 [Registered on: 28/01/2022] Trial Registered Prospectively
Last Modified On: 27/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two drug combination for Laparoscopic Cholecystectomy for post operative pain relief  
Scientific Title of Study   Comparison of intravenous lignocaine with intravenous lignocaine and Magnesium Sulphate combination for Laparoscopic Cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreyas Jaiswal 
Designation  Junior Resident 
Affiliation  IGIMS 
Address  Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  shreyasbony@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alok Kumar 
Designation  Senior resident (SR) 
Affiliation  IGIMS 
Address  Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  alok4138starex@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alok Kumar 
Designation  Senior resident (SR) 
Affiliation  IGIMS 
Address  Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  alok4138starex@gmail.com  
 
Source of Monetary or Material Support  
Dr Alok , department of Anesthesia and ccm , IGIMS , Sheikpura , Patna -800004 
 
Primary Sponsor  
Name  Dr Alok Kumar  
Address  Department of Anesthesia and critical care , IGIMS , Sheikpura, Patna  
Type of Sponsor  Other [Self] 
 
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 Alok Kumar  IGIMS , Sheikpura, Patna  First floor , Ward Block , Department of Anesthesia and CCM , IGIMS , Sheikpura, Patna
Patna
BIHAR 
9028300731

alok4138starex@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, IGIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Infusion of lignocaine post operatively   These patients will receive only intravenous lignocaine 2mg/kg in bolus in 50 ml and maintained at 3mg/kg/hour. 
Intervention  Post op infusion of lignocaine and magnesium sulphate   These patients will receive the combination of intravenous lignocaine and magnesium sulphate 50mg/kg in bolus of 50 ml and maintained at 15 mg/kg/hour and lignocaine at same dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Patients aged 18 to 50 years of both sex undergoing laproscopic cholecystectomy under general anesthesia.

2)ASA 1 and 2.

3)Consenting patients

 
 
ExclusionCriteria 
Details  1)Patient refusal
2)ASA 3 & 4
3)Allergy to drugs
4)Seropositive and COVID 19 positive
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)Quality of recovery score in post operative laproscopic cholecystectomy over 24 hours

2)To compare post-operative analgesia in the group with lignocaine and a group with combination of lignocaine and magnesium sulphate by NRS score at 0, 2, 4, 12 and 24 hour. 
1)Quality of recovery score in post operative laproscopic cholecystectomy over 24 hours

2)To compare post-operative analgesia in the group with lignocaine and a group with combination of lignocaine and magnesium sulphate by NRS score at 0, 2, 4, 12 and 24 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare hemodynamics between the two groups intra-operatively and post operatively.  Intar-operative and post- operative for 24 hours  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   31/01/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Post operative pain management is one of the most crucial step in a health care system. Opioid  such as remifentanil are being used extensively. However  its use are associated with many side effect like respiratory depression, chest wall rigidity, nausea, vomiting, drowsiness, pruritis, urinary retention, immunomodulation and post operativehyperalgesia(a paroxidal side effect of opioid).

Alternative drugs are being studied and lignocaine and magnesium sulphate has been chosen for its lesser side effect and more beneficial. Systemic lignocaine is associated with less post operative pain due to its antinociceptiveantihyperanalgesia and antiinflamatory properties making lesser use of analgesia and general anaesthetic. 

On the other hand magnesium sulphate is NMDA receptor blocker that can prevent central sensitization after peripheral lesion or inflammation in the tissue because of inhibition of NMDA Receptor in the dorsal horn of spinal cord. In this study we compare the effectiveness of intravenous Lignocaine with intravenous Lignocaine and Magnesium sulphate combination for laparoscopic Cholecystectomy.

 
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