FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072395 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 11/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The main outcome of this study is to study the effects of adding Dexmedetomidine to 4 percent Lignocaine nebulization on hemodynamics parameters in participants undergoing endotracheal intubation posted for surgeries under general anaesthesia  
Scientific Title of Study   Effects of adding Dexmedetomidine to 4 Percent Lignocaine nebulization on hemodynamic stress response to laryngoscopy and intubation : A Randomized Control Trial 
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 Lata Devi 
Designation  Anaesthesia resident  
Affiliation  Maharishi Markendeshwar institute of medical sciences and research , Mullana 
Address  Department of Anaesthesia , Maharishi Markendeshwar institute of medical sciences and research , Mullana

Ambala
HARYANA
133207
India 
Phone  9463963930  
Fax    
Email  latadevi728@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lakesh K Anand 
Designation  Professor 
Affiliation  Maharishi Markendeshwar institute of medical sciences and research , Mullana 
Address  Department of Anaesthesia ,Maharishi Markendeshwar institute of medical sciences and research , Mullana

Ambala
HARYANA
133207
India 
Phone  9463963930  
Fax    
Email  lkanand11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lata Devi 
Designation  Anaesthesia resident  
Affiliation  Maharishi Markendeshwar institute of medical sciences and research , Mullana 
Address  Department of Anaesthesia , Maharishi Markendeshwar institute of medical sciences and research , Mullana

Ambala
HARYANA
133207
India 
Phone  9463963930  
Fax    
Email  latadevi728@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia , MM institute of medical sciences and research ,Mullana ,Ambala ,Haryana, India 133207 
 
Primary Sponsor  
Name  Dr Lakesh K Anand 
Address  Department of Anaesthesia , MM institute of medical sciences and research ,Mullana ,Ambala ,Haryana ,India 133207 
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 
Dr Lata Devi  MM Institute of medical sciences and research ,Mullana  Department of Anaesthesia , MM Institute of medical sciences and research ,Mullana
Ambala
HARYANA 		 9463963930

Latadevi728@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,MMIMSR,Mullana,Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  posted for elective surgeries needing endotracheal intubation  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  4% Lignocaine plus Dexmedetomidine nebulization   Group DL: Patient will be nebulized with 4.5 ml 4% Lignocaine plus Dexmedetomidine 1μ/ kg body weight in 0.5ml saline 
Comparator Agent  4% Lignocaine plus 0.5ml of 0.9% Saline nebulization   Group L: Patient will be nebulized with 4.5 ml 4% Lignocaine plus 0.5ml of 0.9% Saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  either gender of age 18-40 ears and ASA I and ASA II status patients posted for elective surgeries requiring endotracheal intubation under general anaesthesia. 
 
ExclusionCriteria 
Details 
Patients with increased risk of regurgitation and aspiration of gastric Contents.
Patients with Difficult airway.
Patients with upper respiratory tract infections
Patients with hepatic or renal insufficiency
Patients with history of smoking or exposure to household smoke.
Patients with Cardiac diseases
Pregnant patients
Patients with known allergy to study drug 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effects on the Heart rate and Blood pressure (SBP, DBP and MAP) in adult patients.
 		 5 minutes before nebulization, immediately intubation, 1minute after intubation,5 minutes after intubation, 30 minutes after extubation
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the postoperative sore throat & pain.  Before nebulization, after intubation, after extubation
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 
Date of First Enrollment (India)   26/08/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Latadevi728@gmail.com].

  6. For how long will this data be available start date provided 10-08-2024 and end date provided 28-03-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Laryngoscopy and endotracheal intubation often trigger significant hemodynamic responses (HDR), such as increased heart rate and blood pressure, lasting at least 10 minutes. These responses are due to sympathoadrenal activation from stretching pharyngeal and laryngeal tissues. While manageable in healthy individuals, HDR can be risky for those with compromised cardiac function. Various anesthetic techniques and medications aim to mitigate these responses.Dexmedetomidine, an alpha-2 adrenoceptor agonist, helps manage haemodynamic response by providing sedation, analgesia, and reducing sympathetic activity, which lowers heart rate and blood pressure. Dexmedetomidine selectively binds to alpha-2A receptors, which affects all three types of alpha-2 receptors. This binding inhibits adenyl cyclase, lowering adenosine monophosphate levels and causing hyperpolarization of noradrenergic neurons. As a result, nerve conduction is suppressed by blocking calcium entry needed for neurotransmitter release, leading to reduced sympathetic activity, lower heart rate, and blood pressure . It can be administered intravenously, intramuscularly, intranasally, buccally, or via nebulization. Lignocaine, a local anesthetic, is used to numb tissues and manage cough during procedures like bronchoscopy and laryngoscopy. Lignocaine is used to manage cough in various clinical scenarios. It has been tested as a spray or gel to suppress acute cough during procedures like bronchoscopy and laryngoscopy. It also helps alleviate postoperative sore throat, cough, and hoarseness, and can be administered via nebulizer for severe cough in terminal patients. As an amide local anesthetic, lignocaine reduces hemodynamic responses to tracheal intubation by acting as a myocardial depressant and having central stimulant effects. Hence the purpose of this study is  to compare the effectiveness of using dexmedetomidine and lignocaine nebulization  together versus each drug alone in attenuating the haemodynamic stress responses to laryngoscopy and endotracheal intubation .

 
Close