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CTRI Number  CTRI/2019/04/018416 [Registered on: 03/04/2019] Trial Registered Prospectively
Last Modified On: 18/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of dexmedetomidine drug through two different routes of administration on suppressing intubation response. 
Scientific Title of Study   A comparative study between Dexmedetomidine nebulisation and intravenous Dexmedetomidine on attenuation of sympathoadrenal response to laryngoscopy and intubation under general anaesthesia  
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Megha V 
Designation  Post graduate student , Department of Anaesthesiology 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, 3rd Floor, Centenary building Victoria Hospital, K.R.Road, Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9538481797  
Fax    
Email  meghavenk7692@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satish Kumar M N 
Designation  Assistant professor, Department of Anaesthesiology  
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, 3rd floor, Centenary building, Victoria Hospital, K.R.Road, Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9916207210  
Fax    
Email  drsats007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha V 
Designation  Post graduate student , Department of Anaesthesiology 
Affiliation  Bangalore Medical College and Research Institute 
Address  Department of Anaesthesiology, 3rd Floor, Centenary building Victoria Hospital, K.R.Road, Bengaluru

Bangalore
KARNATAKA
560002
India 
Phone  9538481797  
Fax    
Email  meghavenk7692@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Megha V 
Address  No 38, Mugilu, 10th B cross, Muneshwara Layout, Laggere 560058 
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 Megha V  Victoria Hospital under Bangalore Medical college & Research Institute   Operation theatre complex, Department of Anaesthesiology, 3rd Floor, Centenary building Victoria Hospital, K.R.Road, Bengaluru 560002
Bangalore
KARNATAKA 		 9538481797

meghavenk7692@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BMCRI ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group DI - Intravenous dexmedetomidine   dexmedetomidine (1mcg/kg) diluted to 10ml is given intravenously over 10 minutes just prior to intubation  
Comparator Agent  Group DN - Dexmedetomidine nebulisation  Dexmedetomidine nebulisation (2mcg/kg) prepared in 3ml of normal saline given over 15 minutes, 30 minutes prior to intubation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who have given written informed consent
2. Patients with ASA grade I & II.
3. Patients aged 18-60 years.
4. Patients with BMI 19-28 kg/m2
5. Patients scheduled for elective surgery under general anaesthesia.
 
 
ExclusionCriteria 
Details  1. Patients not willing to give written informed consent.
2. Patients with history of allergy to dexmedetomidine..
3. Patients with anticipated difficult mask ventilation/difficult intubation.
4. Patients with baseline heart rate < 60 bpm and systolic blood pressure < 100 mm Hg
5. Patients with coronary heart disease, ischemic heart disease, heart blocks, diabetes mellitus.
6. Pregnant women/Breastfeeding mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Dexmedetomidine nebulisation effectively attenuates pressor response to laryngoscopy and intubation when compared to dexmedetomidine given intravenously , efficacy parameter being hemodynamic parameters ( heart rate, systolic BP, diastolic BP, mean arterial pressures, SpO2   Baseline
Before drug
After drug
Before induction
After induction
Immediate after intubation
1 min after intubation
2 min after intubation
5 min after intubation
10 min after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
dexmedetomidine nebulisation may have lesser side effects like bradycardia, hypotension, dizziness ,post operative sedation etc.  Intra-operative
Post-operative till 2 hours  
 
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   N/A 
Date of First Enrollment (India)   20/04/2019 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Laryngoscopy and endotracheal intubation increase the plasma concentration of catecholamines due to sympathetic stimulation which can result in tachycardia and hypertension in most of the individuals. These changes peaks in 1–2 min and returns to normal levels inside 5-10 minutes after intubation. Dexmedetomidine, a selective α2 receptor agonist, decreases sympathetic tone and has been demonstrated to reduce the stress response to laryngoscopy and intubation when given as a premedication intravenously, but studies related to nebulised dexmedetomidine in attenuation of intubation response are not available. Hence this study is designed to compare the efficacy and safety of  dexmedetomidine through nebulisation route.  
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