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CTRI Number  CTRI/2022/11/047245 [Registered on: 14/11/2022] Trial Registered Prospectively
Last Modified On: 13/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL ON THE EFFECT OF DEXMEDETOMIDINE ON TRACHEAL RESPONSE WHEN ADMINISTERED BY INTRANASAL DROP VERSUS NEBULISATION DURING EXTUBATION.  
Scientific Title of Study   EFFICACY OF INTRANASAL DEXMEDETOMIDINE VS ATOMISED DEXMEDETOMIDINE ON TRACHEAL RESPONSE DURING EXTUBATION : A DOUBLE-BLIND RANDOMISED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriya Jena 
Designation  Post graduate 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anesthesiology, KIMS, KIIT University, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8895607770  
Fax    
Email  drsupriyajena@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saswati Das 
Designation  Associate Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anesthesiology, KIMS, KIIT Deemed to be University, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9910760328  
Fax    
Email  das.saswati12@gmail.com  
 
Details of Contact Person
Public Query  
Name  Supriya Jena 
Designation  Post graduate 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anesthesiology, KIMS, KIIT University, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  8895607770  
Fax    
Email  drsupriyajena@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Kalinga Institute of Medical sciences, KIIT Deemed to be University, Bhubaneswar, Odisha 
 
Primary Sponsor  
Name  Self 
Address  Department of Anesthesiology, KIMS, KIIT University, Bhubaneswar, Odisha 
Type of Sponsor  Other [Self funding ] 
 
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 Supriya Jena  Kalinga Institute of Medical Sciences  Operation Theatres, Department of Anesthesiology, KIMS, KIIT Deemed to be University, Bhubaneswar
Khordha
ORISSA 		 8895607770

drsupriyajena@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, KIMS,   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  Intranasal drop of Dexmedetomidine  Group ‘IN’: Patients will receive nasal drops of Dexmedetomidine(1mcg/kg) over 10 seconds and nebulisation with NS over 15 minutes. 
Intervention  Nebulisation with dexmedetomidine  Group ‘N’: Patients will receive nasal drops of NS over 10 seconds and nebulisation with Dexmedetomidine over 15 minutes (1mcg/kg)  
Comparator Agent  Two different intranasal routes of dexmedetomidine  Intranasal drop and nebulisation of dexmedetomidine is compared to see the extubation hemodynamic response.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgeries under general anesthesia
2.American Society of Anesthesiologists (ASA) physical status I and II
3.Age: 20 – 60 Years
4.Surgeries with a duration of 60-120 minutes 
 
ExclusionCriteria 
Details  1.Patients with any nasal pathologies like nasal polyp
2.Patients undergoing upper thoracic and cardiovascular surgeries.
3.History of allergy to the drugs, which will be used in the study.
4.Patients with psychiatric disorders.
5.Patients on anti-hypertensive medications
6.Pregnant women
7.Surgeries with a duration of less than 60 minutes or beyond 150 minutes 
 
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 assess the quality of extubation and stress response during extubation.
 		 1 minute post extubation
3 minutes post extubation
5 minutes post extubation
10 minutes post extubation
15 minutes post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the post-operative sedation score with Ramsay Sedation Score  1. At the time of arrival in post-operative room
2. At 10 minutes after arrival in post-operative room
3. At 20 minutes after arrival in post-operative room
4. At 30 minutes after arrival in post-operative room 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/11/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Dexmedetomidine is a highly selective alpha 2 adrenergic receptor agonist that acts on the locus ceruleus to produce dose dependent sedation with no respiratory depression and only modest hemodynamic effects. The aim is to compare the efficacy of two methods of administering intranasal Dexmedetomidine on the quality of extubation, hemodynamic responses and post operative sedation . 
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