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CTRI Number  CTRI/2023/12/060658 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study of the effect of intraoperative intravenous lignocaine infusion on hemodynamic stability and post operative analgesia in patient undergoing laproscopic cholecystectomy. 
Scientific Title of Study   TO STUDY THE EFFECT OF INTRAOPERATIVE INTRAVENOUS LIGNOCAINE INFUSION ON HEMODYNAMIC RESPONSES AND POST OPERATIVE ANALGESIA IN PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTECTOMY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammed Yunus Khilji  
Designation  Associate professor 
Affiliation  Sardar Patel medical college,Bikaner 
Address  DEPARTMENT OF ANAESTHESIA S.P Medical College ,Bikaner Rajasthan ,INDIA PIN-334001 334001

Bikaner
RAJASTHAN
334001
India 
Phone  8587858715  
Fax    
Email  mohammedyunus.khilji@nhs.net  
 
Details of Contact Person
Scientific Query  
Name  Shilpa Meharra 
Designation  Resident,Department of Anaesthesia 
Affiliation  Sardar Patel medical college,Bikaner 
Address  DEPARTMENT OF ANAESTHESIA S.P Medical College ,Bikaner Rajasthan ,INDIA PIN-334001

Bikaner
RAJASTHAN
334001
India 
Phone  8769077153  
Fax    
Email  shilpaskr1210@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shilpa Meharra 
Designation  Resident,Department of anaesthesia 
Affiliation  Sardar Patel medical college,Bikaner 
Address  DEPARTMENT OF ANAESTHESIA S.P Medical College ,Bikaner Rajasthan ,INDIA PIN-334001

Bikaner
RAJASTHAN
334001
India 
Phone  8769077153  
Fax    
Email  shilpaskr1210@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical College,Bikaner 
 
Primary Sponsor  
Name  Sardar Patel Medical College, Bikaner, Rajasthan 
Address  Department of Anaesthesiology, Sardar Patel Medical College,Bikaner ,Rajasthan PIN 334001 
Type of Sponsor  Government 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 
Mohd yunus khilji  Sardar patel medical college,bikaner rajasthan  Department of anaesthesia,PBM hospital,Bikaner,Rajasthan
Bikaner
RAJASTHAN 		 8587858715

mohammedyunus.khilji@nhs.net 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical and research board ,Sardar Patel Medical College ,Bikaner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal saline  intraoperative lignocaine 2% infusion given at the rate of 2mg/kg/hr till the end of surgery after an induction dose of 1.5mg/kg in patients undergoing laproscoic cholecystectomy under General Anaesthesia,Normal saline is used in same volume as comparator agent as placebo  
Intervention  lignocaine 2%  intraoperative lignocaine 2% infusion given intravenously at the rate of 2mg/kg/hr till the end of surgery after an induction dose of 1.5mg/kg in patients undergoing laproscoic cholecystectomy under General Anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Elective laproscopic cholecystectomy surgeries 
 
ExclusionCriteria 
Details  1.Patient’s refusal .
2.Patients with unanticipated difficult airway i.e more than 1 attempt of intubation or more than 20 seconds intubation time.
3.Patients having known allergy to drug used in study.
4.History of medications affecting heart rate and blood pressure.
5.Patients with history of hypertension, diabetes, hepatic disease ,renal disease, adrenal insufficiency, asthma, psychiatric , endocrine illness , cardiopulmonary disease, obesity.
6.Heart rate <60 beats per minutes.
7.Bleeding disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Hemodynamic stability during laryngoscopy & intubation
2.Hemodynamic stability during intraoperative period
3.Postoperative analgesia  		 Hemodynamic monitoring and VAS score monitoring upto 24 hour after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.Length of hospital stay
2.patient satisfaction 		 24 hour after surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/01/2024 
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   This study is aimed to attain perioperative hemodynamic stability and postoperative analgesia in patient undergoing laproscopic cholecystectomy for better intraoperative and postoperative outcome. 
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