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CTRI Number  CTRI/2021/10/037670 [Registered on: 29/10/2021] Trial Registered Prospectively
Last Modified On: 27/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   DEXMEDETOMIDINE TO REDUCE COUGH AND STRESS RESPONSE DURING EXTUBATION 
Scientific Title of Study   EFFECT OF A SINGLE DOSE OF DEXMEDETOMIDINE ON EXTUBATION STRESS RESPONSE DURING ANAESTHETIC EMERGENCE.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavish S 
Designation  P G Student 
Affiliation  Ramaiah Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY, M. S. RAMAIAH MEDICAL COLLEGE, BENGALURU-560054, KARNATAKA.

Bangalore
KARNATAKA
560054
India 
Phone  7760463025  
Fax    
Email  bhavish.s.reddy@protonmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Leena H Parate 
Designation  Associate professor 
Affiliation  Ramaiah Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY, M. S. RAMAIAH MEDICAL COLLEGE, BENGALURU-560054, KARNATAKA.

Bangalore
KARNATAKA
560054
India 
Phone  8217790902  
Fax    
Email  l_parate@protonmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhavish S 
Designation  P G Student 
Affiliation  Ramaiah Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY, M. S. RAMAIAH MEDICAL COLLEGE, BENGALURU-560054, KARNATAKA.

Bangalore
KARNATAKA
560054
India 
Phone  7760463025  
Fax    
Email  bhavish.s.reddy@protonmail.com  
 
Source of Monetary or Material Support  
Ramaiah Medical College 
 
Primary Sponsor  
Name  Ramaiah Medical College 
Address  DEPARTMENT OF ANAESTHESIOLOGY, M. S. RAMAIAH MEDICAL COLLEGE, BENGALURU-560054, KARNATAKA.  
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 
Bhavish S  Ramaiah Medical College Hospital  Post Graduate, Department Of Anesthesia, M.S. Ramaiah Medical College, Bangalore Bangalore KARNATAKA
Bangalore
KARNATAKA 
7760463025

bhavish.s.reddy@protonmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee M S Ramaiah 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   Single bolus dose of dexmedetomidine 0.5mcg/kg i.v. diluted in 100ml of NS given over a duration of 10 minutes starting half hour prior to expected time of extubation extubation  
Comparator Agent  Normal Saline  100 ml of normal saline given over 10 minutes half hour prior to expected extubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and 2 patients aged between 18 and 60 years scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation. 
 
ExclusionCriteria 
Details  1. Presence of an upper or lower respiratory tract infection.
2. Anticipated difficult airway.
3. Hepatic or renal dysfunction.
4. Poorly controlled hypertension.
5. Surgeries involving the upper airway.
 
 
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 and grade the severity of cough response at the time of extubation.  During anesthetic emergence from surgery. Half hour after administering the test and control agents on the day of intervention only. no long term follow up planned 
 
Secondary Outcome  
Outcome  TimePoints 
To study: a) Hemodynamic response namely heart rate, systolic blood pressures, diastolic blood pressures and mean arterial pressures at the time of extubation. b) Adverse events i.e. desaturation (spo292%), breath holding spells (apnoea15 seconds), laryngospasm, postoperative nausea and vomiting (PONV) at the time of extubation. c) Post-operative sedation.  T0- basal parameters before anaesthetic induction; T1- before extubation; T2- after extubation; T3- 5 minutes after extubation. outcome is assessed on day of intervention only. no long term follow up is planned 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   31/10/2021 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhavish.s.reddy@protonmail.com].

  6. For how long will this data be available start date provided 01-10-2021 and end date provided 01-01-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

           Endotracheal intubation is a commonly used mode of securing and isolating the airway in patients receiving general anaesthesia. This is well tolerated when the patient is under adequate anaesthetic depth. However during emergence from general anaesthesia, an extubation stress response involving cough and adverse hemodynamic changes like tachycardia and hypertension has been identified and studied by various authors. (1-5) It is a significant and alarming event to the patient undergoing extubation and may cause various distressing complications like surgical site re-bleeding, laryngospasm, hypertension, myocardial ischemia, oxygen desaturation, and violent behavior leading to injury to the patient, healthcare personnel and support staff. (1,2) It is desirable to avoid these unfavourable changes in patients during the time of extubation after surgery.

Many pharmacologic agents like lignocaine, opioids, calcium channel blockers, esmolol, magnesium sulphate, propofol, etc. have been shown to attenuate these responses. (2,3,6) Dexmedetomidine is one such drug. It is an alpha-2 adrenergic receptor agonist. It finds use in the intensive care setting for sedation of intubated patients and also in non-intubated patients for sedation in the perioperative period without depressing the respiratory drive. (2) It has been used in various doses ranging from 0.5mcg/kg to 1mcg/kg; with all doses providing adequate sedation but higher doses increasing the risk of adverse hemodynamic outcomes. (4)  It has also been found that a single bolus administration of dexmedetomidine is associated with a lower incidence of emergence delirium and pain scores as compared to a continuous infusion. (5) Thus, a single bolus dose of dexmedetomidine is an easy and straightforward technique to reduce extubation stress response.

            We intend to study the effect of a single bolus dose of dexmedetomidine on the prevention of cough response at the time of extubation. We also intend to study hemodynamic changes, adverse events and post-operative sedation over the course of emergence from general anaesthesia.

 
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