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CTRI Number  CTRI/2025/01/079632 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 23/12/2024
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   A comparative study of preoperative nebulization of Dexmedetomidine versus Lignocaine in patients undergoing elective laparoscopic surgeries under general anaesthesia. 
Scientific Title of Study   Comparison of Preoperative Nebulization of Dexmedetomidine Versus Lignocaine in Attenuating Hemodynamic Response to Direct Laryngoscopy and Endotracheal Intubation in Patients Undergoing Elective Laparoscopic Surgeries: A Randomized Double Blinded Clinical Study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith P Gowda  
Designation  Junior Resident-I 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No. 1, 3rd Floor, Department of Anaesthesiology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9108882836  
Fax    
Email  harshithprakashg17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kumar P B 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No. 1, 3rd Floor, Department of Anaesthesiology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9448279414  
Fax    
Email  drrameshkumarpb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kumar P B 
Designation  Professor and HOD 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Room No. 1, 3rd Floor, Department of Anaesthesiology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9448279414  
Fax    
Email  drrameshkumarpb@gmail.com  
 
Source of Monetary or Material Support  
BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India  
 
Primary Sponsor  
Name  BGS Global Institute of Medical Sciences 
Address  No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India 
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 
Dr Harshith P Gowda   BGS Global Institute of Medical Sciences  Room No. 1, 3rd Floor, Department of Anaesthesiology, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA 		 9108882836

harshithprakashg17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  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  Nebulization of 4% Lignocaine 3mg/kg   Single Dose of 5ml Nebulization of 4% Lignocaine 3mg/kg for 20 minutes  
Intervention  Nebulization of Dexmedetomidine 1mcg/kg + 0.9% NS  Single Dose of 5ml Nebulization of Dexmedetomidine 1mcg/kg + 0.9% NS for 20 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients willing to give informed written consent 2. American Society of Anaesthesiologists class I and II 3.Patients with normal airway on examination 4.Patients undergoing elective laparoscopic surgeries under general anaesthesia with endotracheal intubation with a duration of 2 to 4 hours are included in the study.
 
 
ExclusionCriteria 
Details  1.Individuals with BMI more than 30 kg per meter square 2.Mallampati grading more than 2 3.Anticipated difficult intubation requiring more than 15 seconds for intubation or more than two attempts at laryngoscopy 4.Patients with allergy to Dexmedetomidine and Lignocaine 5.Taking medicines such as Beta blockers, Clonidine, Gabapentin, Pregabalin, Anti-convulsant, Anti-psychotics 6. Pregnant patients are excluded from the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effects of preoperative nebulized Dexmedetomidine (1mcg per kg) and Nebulized Lignocaine 4% (3mg per kg) on the hemodynamic response to laryngoscopy and intubation by monitoring vitals
 		 Post Intubation at 1min, 3min, 5min, 10min, 15min, 30min, 45min, 60min, 90min, 120min, 150min, 180min, 210min and 240min. 
 
Secondary Outcome  
Outcome  TimePoints 
Amount of Inj Fentanyl consumed intra-operatively  Post Intubation at 1min, 3min, 5min, 10min, 15min, 30min, 45min, 60min, 90min, 120min, 150min, 180min, 210min and 240min. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 4 
Date of First Enrollment (India)   01/02/2025 
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="1"
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   Direct laryngoscopy and tracheal intubation following induction of anaesthesia are associated with hemodynamic changes due to increased sympathoadrenal activity which may result in hypertension and tachycardia.Multiple drugs have been used to blunt the hemodynamic response during endotracheal intubation one of them is Dexmedetomidine which is a highly selective alpha 2 agonist which has sympatholytic, sedative analgesic and amnestic properties.Another drug is Lignocaine which is an amide local anaesthetic which reduces the excitation of airway sensory fibres. Thus, in this study we compare the effects of pre-operative nebulization of Dexmedetomidine 1mcg/kg and 4% Lignocaine 3mg/kg on the haemodynamic response during endotracheal intubation in Patients Undergoing Elective laparoscopic surgeries.  
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