FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/10/037396 [Registered on: 20/10/2021] Trial Registered Prospectively
Last Modified On: 17/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of lidocaine and dexmedetomidine to see anaesthetic sparing effect in laparoscopic surgery 
Scientific Title of Study   Perioperative infusion of lidocaine vs dexmedetomidine - anaesthetic sparing effect in laparoscopic surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajeev Ranjan 
Designation  Junior Resident 
Affiliation  IGIMS 
Address  ward block, 1st floor, Department of Anesthesia and CCM ,IGIMS, Sheikpura , Patna
ward block, 1st floor,Department of Anesthesia and CCM ,IGIMS, Sheikhpura, Patna
Patna
BIHAR
800014
India 
Phone  8603746104  
Fax    
Email  rjvranjan50@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  IGIMS 
Address  Ward block 1st floor , Department of Anesthesia and CCM,IGIMS , Sheikpura , Patna

Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mumtaz Hussain 
Designation  Additional Professor 
Affiliation  IGIMS 
Address  Ward block 1st floor , Department of Anesthesia and CCM,IGIMS , Sheikpura , Patna

Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Source of Monetary or Material Support  
Self , IGIMS , Patna  
 
Primary Sponsor  
Name  Rajeev Ranjan  
Address  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 
Rajeev Ranjan   IGIMS , Patna  Department of Anesthesia and CCM , ward block , 1st floor
Patna
BIHAR 
8603746104

rjvranjan50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   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 
Intervention  Perioperative infusion of dexmedetomidine   Patients in this group will receive a loading dose of iv. bolus dexmedetomidine 1mcg/kg diluted upto 20 ml by adding normal saline slowly for 10 minutes followed by iv. Infusion 0.5 mcg/kg/hr diluted upto 20 ml/hr till 10 min before the end of surgery. 
Intervention  Perioperative infusion of intravenous lidocaine  Patients in this group will receive a loading dose of iv bolus lidocaine 1.5 mg/kg diluted upto 20 ml by adding normal saline slowly for 10 min followed by iv. Infusion 2mg/kg/hr diluted upto 20ml/hr using infusion pump till 10 min before the end of surgery. 
Comparator Agent  Perioperative infusion of normal saline   Patients in this group will receive iv. Bolus 0.9% normal saline slowly for 10 minutes followed by iv. Infusion of normal saline 20ml/hr till 10 min before the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of ASA physical status I and II.
2. Patients willing to participate.
3. laproscopic surgery of different types under general anesthesia.
4. Patient between 18-65years of either sex . 
 
ExclusionCriteria 
Details  a. Patients refusal to participate..
b. American Society of Anesthesiologists physical status of 3 or higher.
c. Patients with known allergy to any of the study drugs and
with cardiac conduction defects. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison between lidocaine vs dexmedetomidine regarding anaesthetic sparing effect in laproscopic surgery.
1.Propofol induction dose
2.End tidal isoflurane
3.Intra operative fentanyl required
4.Post operatively first analgesic demand 
anesthesia induction till und of surgery and the time to the first postoperative analgesic requirement in patients who undergo elective laparoscopic surgeries under general anesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
• Peri operative hemodynamic changes
• Post operative nausea, vomiting
• Bowel function (ileus)
• Bradycardia, if any 
anesthesia induction till und of surgery and the time to the first postoperative analgesic requirement in patients who undergo elective laparoscopic surgeries under general anesthesia. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/10/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Lidocaine is an amide local anesthetic has analgesic, antihyperalgesic, and anti- inflammatory effects due to sodium channel blockade and inhibition of N-methyl- D-aspartate (NMDA) receptors [1]. Intravenous lidocaine provides pain relief after open abdominal surgery and laparoscopic surgery.
[2]
Use of perioperative lidocaine infusion include reductions in pain, nausea, ileus duration, opioid requirement, and length of hospital stay [3-8]. Lidocaine has a stabilizing effect on the heart and blood pressure, possibly by direct myocardial depressant effect, a peripheral vasodilating effect, and through its anti- inflammatory activity.
[9]
Dexmedetomidate, an imidazole compound is a pharmacologically active dextroisomer of medetomidine that displays specific and selective α2-adrenoceptor agonism. Activation of these receptors in the brain and spinal cord inhibits neuronal firing, causing hypotension, bradycardia, sedation, and analgesia. Dexmedetomidine is a specific alpha 2adrenergic receptor agonist that has anti- nociceptive and sedative properties.
Intravenous dexmedetomidine has a role as postoperative analgesia, which leads to the reduced requirement for opioids
[10-13] The goal of the current study is to compare the effects
 Perioperative lidocaine infusion is commonly used as analgesic adjunct in
 enhanced recovery protocols for patients undergoing laparoscopic
 surgeries to control the intraoperative and postoperative pain scores,
 decrease opioid consumption, and shorten length of hospital stay and
 increase patients comfort (Terkawi et al. 2016).
 Dexmedetomidine was a selective alpha 2 agonist as clonidine, but it has a greater
 affinity to the alpha 2 receptor with hypnotic properties similar to natural sleep and
 effectively attenuates the stress response to the surgical intervention with minimal
 or no respiratory depression complication. Also, maintained hemodynamic stability
 through its function on the central and peripheral alpha 2 receptors leads to
 reduction of heart rate and the systemic vascular resistance (Bos et al. 2017).
  
  of perioperative intravenous lidocaine and dexmedetomidine
  on the anesthetic consumption, anesthesia induction, recovery
  times, and the time to the first postoperative analgesic
  requirement in patients who undergo elective laproscopic
  surgeries under general anesthesia.
 
Close