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CTRI Number  CTRI/2024/07/070396 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of nebulized dexmedetomidine versus nebulized magnesium sulphate on reducing intubation response  
Scientific Title of Study   Comparison of hemodynamic effects of nebulized dexmedetomidine versus nebulized magnesium sulphate on attenuation of stress response during laryngoscopy and tracheal intubation- A randomized control trial 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yuvaraj karthikeyan 
Designation  PG Registrar 
Affiliation  Christian Medical College 
Address  Department of Anesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9597113780  
Fax    
Email  yuvarajkarthi1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Balaji Kuppuswamy 
Designation  Professor 
Affiliation  Christian Medical College 
Address  Department of Anesthesiology, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7406777127  
Fax    
Email  balooswamy@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christain Medical College, Vellore- 632004 Tamilnadu, India 
 
Primary Sponsor  
Name  Yuvaraj karthikeyan 
Address  Dr Yuvaraj Karthikeyan, Department of Anesthesiology, Christian Medical College,Vellore- 632004, Tamilnadu, India 
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 Yuvaraj Karthikeyan  Christian Medical College  Department of Anesthesiology, Christian Medical College, Vellore
Vellore
TAMIL NADU 
9597113780

yuvarajkarthi1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Committee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulized Dexmedetomidine  Nebulized dexmedetomidine 1mcg per kg over 15 minutes, 10minutes prior to induction and Hemodynamic responses to laryngoscopy is observed 
Comparator Agent  Nebulized Magnesium sulphate  Nebulized Magnesium sulphate 10mg per kg over 15 minutes, 10minutes prior to induction and hemodynamic responses to laryngoscopy is observed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective surgery and belonging to ASA physical status I to II
 
 
ExclusionCriteria 
Details  Patients with difficult airway, uncontrolled hypertension, heart disease with ejection fraction less than 40%, body mass index more than 35 kg/m2, history suggestive of hypersensitivity to drugs used during the study, bradycardia- heart rate less than 50 beats per minute, any heart block, hepatic impairment, renal impairment and pregnancy.  
 
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 
To compare the hemodynamic effects of preoperative nebulized dexmedetomidine and nebulized magnesium sulphate on laryngoscopy and intubation stress response attenuation  1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the requirement of additional anesthetic drugs(fentanyl, propofol)in order to maintain the hemodynamics within 20% of baseline values  1 hour 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
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)   07/08/2024 
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="0"
Months="8"
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  

The purpose of this study is to compare the effect of preoperative nebulised dexmedetomidine and nebulized magnesium sulphate  on hemodynamic responses to laryngoscopy and endobronchial intubation . Patients coming for elective  surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period. Patients will be divided into two groups by computer-generated block randomization: Group A will receive dexmedetomidine(1mcg/kg body weight diluted with normal saline 4ml administered over 10-15 minutes ) and Group B will receive nebulized magnesium sulphate (10mg/kg with normal saline 4ml administered over 10-15 minutes)

All patients will have standard ASA monitoring with one intravenous (IV) lines.

Five minutes after completion of nebulization with the study drug, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 2 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital.  Anesthesia will be maintained with isoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and endotracheal tube insertion. Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 5mg or Phenylephrine 25-50 mcg . Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypertension, hypotension , tachycardia and bradycardia will be documented and the number of doses of rescue medication administered will be noted.

 

 
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