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CTRI Number  CTRI/2025/01/078858 [Registered on: 16/01/2025] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparision between intratracheal vs intravenous dexmedetomidine during tracheal extubation under general anaesthesia  
Scientific Title of Study   A Prospective Randomized Comparative Study to Compare the Efficacy of Intratracheal Dexmedetomidine versus Intravenous Dexmedetomidine in Attenuating Periextubation Cough and Hemodynamic Stress Response during Tracheal Extubation under General Anaesthesia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishal Babubhai Hadiya 
Designation  Resident Doctor 
Affiliation  Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India

Vadodara
GUJARAT
391760
India 
Phone  8469620185  
Fax    
Email  vishalhadiya098@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jatin Patel 
Designation  Professor 
Affiliation  Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India

Vadodara
GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  dr_jatinpatel@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jatin Patel 
Designation  Professor 
Affiliation  Smt.Bhikhiben Kanjibhai Shah Medical Institute & Research Centre 
Address  Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India

Vadodara
GUJARAT
391760
India 
Phone  9879368363  
Fax    
Email  dr_jatinpatel@yahoo.co.in  
 
Source of Monetary or Material Support  
Smt Bhikhibem Kanjibhai Shah Medical Institute and Research centre, Waghodia, Pipariya, Vadodara, Gujarat, India - 391760 
 
Primary Sponsor  
Name  Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia, Pipariya, Vadodara, Gujarat, India - 391760 
Type of Sponsor  Private medical college 
 
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 Jatin Patel  Smt Bhikhiben Kanjibhai Shah Medical Institute and Research Centre  Smt Bhikhiben Kanjibhai Medical Institute and Research Centre, waghodia, Pipariya, Vadodara, Gujarat, India 391760
Vadodara
GUJARAT 		 9879368363

dr_jatinpatel@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  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  Intra Tracheal Dexmedetomidine 0.3mcg/kg  Intra Tracheal Dexmedetomidine 0.3 mcg/kg (diluted till 1 ml) 30 minutes prior to tracheal extubation of general anaesthesia 
Comparator Agent  Intravenous Dexmedetomidine 0.3 mcg/kg  Intravenous Dexmedetomidine 0.3 mcg/kg (diluted till 10 ml) 30 minutes prior to tracheal extubation of general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients voluntarilly willing to sign informed consent.
2. Male or female patients between 18 to 60 years of age.
3. Patients belonging to American Society of Anesthesiologists (ASA) physical status
I and II.
4. Patients posted for elective surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  1. Patients unwilling to participate in the study.
2. Patients with American society of Anesthesiiologist (ASA) physical status III, IV,
V
3. Patients with Body Mass Index ≥ 30 kg/m2

4. Patients with anticipated difficult airway& intubation.
5. Patient with preexisting hoarseness or sore throat or upper respiratory tract
infection.
6. Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta
blockers or any antihypertensive treatment.
7. Patients with cerebrovascular, hepatic and renal diseases.
8. Patient using steroids or having history of asthma or COPD.
9. Patients with history of allergy to an α-2 adrenergic agonist
10. Pregnancy & lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of attenuating peri-extubation cough using 4 point cough scale during tracheal extubation  At time of awareness
At time of Extubation
After extubation
At 1 min
At 2 min
At 3 min
At 5 min 
 
Secondary Outcome  
Outcome  TimePoints 
To study the post operative sedation score   Ramsay Sedation Score (RSS) will be recorded till the patient achieve RSScore 2 
To study the haemodynamic stress responses during extubation  Preoperative
After induction
At laryngoscopy
At intubation
5 min before drug administration
At time of drug administration
aftrer drug administration
At 5 mins after drug
AT 10 mins after drug
At the end of surgery
At point of awarness
During Extubation
After extubation
At 2 min
At 5 min
At 15 min
At 30 min 
To study the duration of analgesia by Visual Analogue Score (VAS) score and side effects if any  VAS will be recorded till the patient achieves VAS 4 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 4 
Date of First Enrollment (India)   31/01/2025 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  dr_jatinpatel@yahoo.co.in

  6. For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A study to compare the efficacy of intra tracheal dexmedetomidine versus intravenous dexmedetomidine in attenuating peri extubation cough and hemodynamic responses during tracheal extubation under general anaesthesia

Objective is to study the efficacy of attenuating peri-extubation cough using 4 point cough scale during tracheal extubation,To stud the post operative sedation score, to study the haemodynamic stress responses during extubation, To study the duration of analgesia by Visual Analogue Score (VAS) score and side effects if any

 Inclusion criteria 
•Patients voluntarily willing to sign written & informed consent.
•Male or female patients between age group of 18 to 60 years of age.
•Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
•Patients posted for elective surgeries under general anaesthesia.

Exclusion criteria
•Patients unwilling to participate in the study.
•Patients with American Society of Anaesthesiologists (ASA) physical status III,

       IV

•Patients with Body Mass Index ≥ 30 kg/m2
•Patients with anticipated difficult airway & intubation.
•Patients with preexisting hoarseness or sore throat or URTI.
•Patients with cardiovascular disease, arrhythmias, heart blocks, or taking beta

      blockers or any antihypertensive treatment.

•Patients with cerebrovascular, hepatic and renal disease.
•Patients using steroids or having history of asthma or COPD.
•Patients with history of allergy to an α-2 adrenergic agonist.
Pregnancy & lactating women
Site of study  S.B.K.S. Medical Institute and Research Centre, Sumandeep Vidhyapeeth University, Piparia, Vadodara, Gujarat
Study design    observational comparative study
Study Duration  : The study will be initiated after obtaining permission from institutional ethics  committee till the achievement of the sample size or by 18 months whichever is earlier.
       Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student–t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables, chi–square test will be used. P value<0.05 will be considered statistically significant.

Likely outcome/ Benefit :This prospective comparative study will help us to compare the efficacy between intratracheal dexmedetomidine and intravenous dexmedetomidine in attenuating peri extubation cough and hemodynamic stress responses to tracheal extubation in patients undergoing surgeries under general  anaesthesia and will enable us to know which route of the dexmedetomidine drug is most beneficial in giving balanced general anaesthesia by having better outcomes in cough reflexes and hemodynamics and less post operative complications

 
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