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CTRI Number  CTRI/2022/09/045139 [Registered on: 01/09/2022] Trial Registered Prospectively
Last Modified On: 27/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of Dexmedetomidine nebulisation to reduce the blood pressure following Endotracheal intubation. 
Scientific Title of Study   Effect of preanaesthetic dexmedetomidine nebulization in hemodynamic responses following laryngoscopy and intubation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deeksha B G  
Designation  Post Graduate 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL 
Address  OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore
KADUGONDANAHALLI BENGALURU 560045
Bangalore
KARNATAKA
560045
India 
Phone  9480175763  
Fax    
Email  deekshambbs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Reshma B M 
Designation  Associate professor  
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL 
Address  OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore
KADUGONDANAHALLI BENGALURU 560045
Bangalore
KARNATAKA
560045
India 
Phone  8892019120  
Fax    
Email  lucky3276@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deeksha B G  
Designation  Post Graduate 
Affiliation  DR B R AMBEDKAR MEDICAL COLLEGE HOSPITAL 
Address  OT complex 1st floor, Dr BR Ambedkar medical College, KG Halli , Bangalore
KADUGONDANAHALLI BENGALURU 560045
Bangalore
KARNATAKA
560045
India 
Phone  9480175763  
Fax    
Email  deekshambbs@gmail.com  
 
Source of Monetary or Material Support  
Dr. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL  
 
Primary Sponsor  
Name  Dr Deeksha B G 
Address  OT complex, department of anaesthesia, Dr. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BANGALORE  
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 Deeksha   Ot complex  Dr. B. R. Ambedkar medical College and hospital, Bangalore
Bangalore
KARNATAKA 
9480175763

deekshambbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee Dr BR Ambedkar Medical College   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  Dexmedetomidine nebulisation   Patients posted for surgery under general anaesthesia with Endotracheal intubation will be given dexmedetomidine nebulization 1mcg/kg body weight 45min before intubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients posted for surgery under general anaesthesia with Endotracheal intubation
 
 
ExclusionCriteria 
Details  Patients with Difficult Airway
Pregnancy and Lactation  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of pre operative dexmedetomidine nebulization on mean arterial pressure following laryngoscopy and intubation   First 5 minutes and 10th minute following laryngoscopy and intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the heart rate
Following laryngoscopy and intubation  
At first 5 minutes and 10th minute following laryngoscopy and intubation  
Sedation score   Pre operatively from the start of nebulization till end of nebulization for every 5 minutes  
Total doses of propofol used  At the time of induction  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/09/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Direct laryngoscopy and intubation are noxious stimuli and are associated with transient but unpredictable and variable haemodynamic changes. This response occurs within 30 seconds after intubation and lasts less than 10 minutes. The consequences of laryngoscopy and intubation may precipitate ischemia, arrhythmias, cerebrovascular stroke, pulmonary oedema, increase in intracranial pressure in vulnerable group. Till date, numerous drugs and various routes have been tried to attenuate this stress response such as opioids, vasodilators, beta blockers, calcium channel blockers, intravenous lignocaine but none of the agents proved to be ideal.
Dexmedetomidine is a highly selective alpha 2 adrenoreceptor agonist. It is a short acting drug having sympatholytic, sedative, hypnotic, anxiolytic, analgesic and anti-sialogogue properties. Its pleiotropic effect have led to its increasing use for reducing anaesthesia and analgesic requirements in the perioperative period. 

The efficacy of dexmedetomidine in attenuating the hemodynamic response to laryngoscopy and intubation has been studied through intravenous, intranasal and intramuscular routes. However, it is noted that intravenous administration causes bradycardia, hypotension and even cardiac arrest [2] and intranasal administration may be associated with nasal irritation, cough, vocal cord irritation or laryngospasm.
Inhalation of nebulized drug is an alternative method of administration that is relatively easy to set up, does not require venipuncture, and is associated with high bioavailability of the administered drug. 

Nebulised dexmedetomidine has been used as an effective premedication in paediatric patients in the doses of 1 and 2mcg/kg. Few studies are available which have evaluated either 1 or 2 mcg/kg dexmedetomidine in attenuating stress response to intubation. Hence, our study and we hypothesize that dexmedetomidine nebulisation at 1 mcg/kg provides good haemodynamic stability and sedation.
 
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