FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/10/028697 [Registered on: 28/10/2020] Trial Registered Prospectively
Last Modified On: 28/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of propofol sparing effect of intravenous lignocaine in patients undergoing daycare upper Gastro Intestinal endoscopic procedures 
Scientific Title of Study   Evaluation of propofol sparing effect of intravenous lignocaine in patients undergoing daycare upper G.I. endoscopic procedures 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Patna
BIHAR
800014
India 
Phone  9973152076  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Patna
BIHAR
800014
India 
Phone  9973152076  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Patna
BIHAR
800014
India 
Phone  9973152076  
Fax    
Email  drhussain72@yahoo.co.in  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences,Patna 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences 
Address  Indira Gandhi Institute of Medical Sciences Sheikhpura Patna 
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 
Mumtaz Hussain  Indira Gandhi Institute of Medical Sciences  Department of Anaesthesiology Indira Gandhi Institute of Medical Sciences Sheikhpura Patna
Patna
BIHAR 		 9973152076

drhussain72@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K831||Obstruction of bile duct,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lignocaine   Patients will receive perioperative intravenous bolus of 1.5 mg/kg lignocaine over 10 seconds (2% lignocaine) followed by 4 mg/ kg/ hour continuous lidocaine infusion (0.5% lignocaine) 
Comparator Agent  Normal saline  Patients will receive perioperative intravenous bolus of 1.5 ml/kg normal saline over 10 seconds followed by continuous infusion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age 18-65 years
ASA Grade-I & II
Undergoing day care upper G.I. endoscopic procedures under sedation
 
 
ExclusionCriteria 
Details  Patient refusal
ASA Grade-III & IV
Unstable hemodynamic status
Mental disorders, such as schizophrenia and psychosis on long-term psychotropic drugs
Hyperalgesia or refractory cancer pain
Allergic to study agent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Total amount of propofol administered during the procedure
2. Total supplemental amount of propofol after induction and
3. Number of boluses of supplemental propofol
 		 After procedure  
 
Secondary Outcome  
Outcome  TimePoints 
Recovery scores
VAS score 		 postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/10/2020 
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)   Not Applicable 
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   Sedation protocol employed during endoscopic procedures might hinder early recovery and discharge from hospital.We intend to observe whether addition of lignocaine to sedation protocol help early discharge from hospital. 
Close