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CTRI Number  CTRI/2025/10/095744 [Registered on: 08/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on hemodynamic stability in patient undergoing general anaesthesia 
Scientific Title of Study   Comparison of Effects of Intravenous Dexmedetomidine and 2 percentage Lignocaine in Perioperative Hemodynamic stability and Post Operative Recovery profile in Laparoscopic Surgery  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  professor pushparani 
Designation  professor in department of anaesthesiology 
Affiliation  Professor 
Address  room no-5,4th floor,SRM medical college hospital and research centre,kattankulathur,chengalpattu district
room no 5,4th floor,SRM medical college hospital and research centre,kattankulathur-603203
Chennai
TAMIL NADU
603203
India 
Phone  9003242601  
Fax    
Email  pushpa82_dr@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Pushparani 
Designation  Professor in Department of Anaesthesiology 
Affiliation  Professor 
Address  room no 5,4th floor,SRM medical college hospital and research centre, kattankulathur,chengalpattu district,603203
SRM medical college hospital and research centre,kattankulathur,603203
Chennai
TAMIL NADU
603203
India 
Phone  9003242601  
Fax    
Email  pushpa82_dr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  yuvaraj p 
Designation  post graduate student 
Affiliation  PG 
Address  Room no5,4th floor,SRM medical college hospital and research centre, kattankulathur,603203
SRM medical college hospital and research centre,kattankulathur-603203
Chennai
TAMIL NADU
603203
India 
Phone  9884420162  
Fax    
Email  yuvaraj5596@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District.Pincode-603203 
 
Primary Sponsor  
Name  SRM Medical College Hospital and Research centre kattankulathurchengalpattu district  
Address  SRM medical college hospital and research centre 603203 
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 
Yuvaraj P  SRM Medical College Hospital and Research Centre  SRM Medical College Hospital and Research Centre,Kattanl kulathur,Chengalpattu District
Chennai
TAMIL NADU 
9884420162

yuvaraj5596@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 
Comparator Agent  Group D Dexmedetomidine  Patient in group D receive dexmedetomidine 0.5 microgram per kilogram loading dose over 10 minutes followed by 0.5 microgram per kilogram per hour infusion 
Intervention  group L- Lignocaine 2%  Group-L receive lidocaine hydrochloride (1.5 mg/kg slow bolus, followed by 1.5 mg/kg/hr infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA PS I - II class patients.
Patients undergoing elective laparoscopic surgery.
surgical procedure duration less than 02 hours 
 
ExclusionCriteria 
Details  patients refusal to be part of research.
Heart rate less than 60/min and MAP less than 65mmHg
History of hypersensitivity to the study drug.
chronic use of opioids/opioid addiction, steroids and inability to comprehend postoperatively the pain assessment scale.
Neuropsychiatric disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation  Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation 
 
Secondary Outcome  
Outcome  TimePoints 
Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability & post operative pain relief without excess sedation  from the time of premedication every three minutes for first
twenty minutes & then every ten minutes thereafter till extubation 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/11/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
 Aim is to compare the effects of  intravenous lignocaine and dexmedetomidine on  perioperative hemodynamic parameters in patients undergoing laparoscopic surgeries
Primary objective is to analyse the effects of perioperative hemodynamic stability.Secondary objective is to analyse the  intubation response,time to extubate,postoperative pain relief and pain at discharge from recovery in patients undergoing laparoscopic surgeries.A prospective,interventional,single centric, double blinded, randomized control trial.clinical study will be conducted after getting approval from the Institutional Ethical Committee.Patients were familiarized with the 10-point Visual Analog Scale VAS during the preanesthetic visit. In the operating room, standard multiparameter monitors were connected.Patients in Group D receive dexmedetomidine 0.5microgram per kilogram loading dose over 10 minutes, followed by 0.5 microgram per kilogram per hour infusion, while Group-L receive lidocaine hydrochloride 1.5 mg per kg slow bolus, followed by 1.5 milligram per kilogram per hour infusion,while Group-P 0.9 percentage Normal saline. Anesthetic induction was achieved with fentanyl 2.5  microgram per kilogram  and propofol 2 milligram per kilogram until loss of verbal command. Endotracheal intubation was performed with Atracurium 0.5mg per kilogram.  Anesthesia was maintained with an oxygen/air/sevoflurane mixture 1 MAC and atracurium. After induction continuous hemodynamic parameters is monitored in regular predefined time scale through out the procedure.Intraabdominal pressures,end tidal Co2 and MAC is monitored through out the procedure.After the specific specimen is out, then sevoflurane and study drug infusion will be stopped and extubation will stared after 20-30  minutes from the time of specimen out.Residual neuromuscular blockade was reversed with neostigmine 0.05 milligram per kilogram and glycopyrrolate 0.005 milligram per kilogram. Immediately after extubation, RASS and VAS score is assessedand 20 minutes after extubation repeat VAS will be  monitored.Patients were transferred to the post anesthesia care unit PACU after successful tracheal extubation. Heart rate HR and mean arterial pressure MAP were monitored at regular intervals. Hypotension 20 percentage MAP fall below baseline) was managed with crystalloid boluses and Phenylepherine 10-50 microgram. Bradycardia HR < 45 beats/min was managed with IV atropine 0.6 milligram.

 
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