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CTRI Number  CTRI/2024/08/072540 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Preventing post operative sore throat in patients,comparison of two drugs 
Scientific Title of Study   To determine the efficacy of dexmedetomidine and dexamethasone nebulisation in preventing sore throat in patients undergoing general anesthesia: A randomised double blind comparative study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shruthi KS 
Designation  Junior resident  
Affiliation  Rajarajeswari Medical College and hospital  
Address  Department of Anaesthesiology Rajarajeswari Medical College and hospital, mysore Road

Bangalore
KARNATAKA
560074
India 
Phone  9945353471  
Fax    
Email  ks.shruti55@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nadia  
Designation  Associate Professor 
Affiliation  Rajarajeswari Medical College and hospital  
Address  Department of Anaesthesiology Rajarajeswari Medical College and hospital, mysore Road

Bangalore
KARNATAKA
560074
India 
Phone  9945353471  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shruthi KS 
Designation  Junior resident  
Affiliation  Rajarajeswari Medical College and hospital  
Address  Department of Anaesthesiology Rajarajeswari Medical College and hospital, mysore Road

Bangalore
KARNATAKA
560074
India 
Phone  9945353471  
Fax    
Email  ks.shruti55@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College & Hospital Bangalore Karnataka 560074 
 
Primary Sponsor  
Name  Rajarajeswari Medical College and Hospital 
Address  202 Mysore Road, Kengeri Satellite Town, Kambipura, Karnataka, 560074 
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 Shruthi   Rajarajeswari medical college   Room number 1249, Department of Anaesthesiology Rajarajeswari medical college, Mysore road 560074
Bangalore
KARNATAKA 
9845972475

KS.SHRUTI55@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL 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 
Comparator Agent  Dexamethasone   Nebulisation with dexamethasone given pre operatively for patients undergoing general anesthesia for endotracheal intubation at a dose of 8mg with 3ml normal saline to a total of 5ml  
Intervention  Dexmeditomidine   Nebulization with dexmedetomidine given pre operatively to patients posted for general anesthesia for endotracheal intubation at a dose of 50 mcg/ml with 4ml normal saline to a total of 5ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA I and II patients of either sex
2.Patients aged between 18 to 60years
3.Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation  
 
ExclusionCriteria 
Details  1.History of allergy to study drug.
2.Pre operative sore throat
3.Upper respiratory infection or COPD
4.Pregnancy
5.Anticipated difficult airway
6.Cormack and Lehane grade are 3 or 4, duration of laryngoscopy more than 15 seconds,more than one
intubation attempts
7.Intraoperative deterioration preventing extubation
8.Anesthesia lasting over two hours
9. Naso gastric tube insertion
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
study is to evaluate and compare the efficacy of dexmedetomidine
and dexamethasone nebulisation in preventing sore throat in patient undergoing
general anesthesia  
0 hour, 2hours ,4hours ,6hours 12hours and 24hours post operative  
 
Secondary Outcome  
Outcome  TimePoints 
study side effects such as dry mouth, cough, PONV, hemodynamic
instability. 
24hours post operative  
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   26/08/2024 
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 Yet Recruiting 
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 - NO
Brief Summary        Methodology of Study
After obtaining institutional ethical committee approval, a randomized comparative
study will be carried out.
A written and informed consent will be taken from the patient after explaining the
purpose, the procedure and risks involved with the study.
63 patients of ASA 1 and ASA 2 aged between 18 and 60 years scheduled for elective
surgeries under general anaesthesia will be selected based on inclusion or exclusion
criteria as mentioned above.
All patients will be subjected to detailed preanesthetic evaluation. Routine and specific
investigations will be done as per patients clinical evaluation along with optimization.
All patients will be evaluated a day before the surgery. Patients will be kept NPO as per
the ASA guidelines before the procedure.
Eligible patients will be randomly allocated using computer formulated randomization
technique and opaque sealed envelopes by anesthesiology technician who will not take
part in the study. After opening those envelopes, the nebulization solution will be
prepared by anesthesia assistant (who will not take part in the study) according to the
assigned group.
GROUP A- Patient will receive nebulization dexmedetomidine 50 mcg/ml mixed with
4ml normal saline to a total volume of 5ml given over 15 minutes
GROUP B- patient will receive nebulization dexamethasone 8mg (2ml) mixed with
normal saline to a total volume of 5ml given over 15 minutes
GROUP C- patient will receive nebulisation with normal saline 5ml given over 15mins
Patients will be unaware of their treatment as the nebulized substances are colorless,
odourless and tasteless.
Upon arrival at the operating room’s waiting area, patients will undergo re-examination
for identification, diagnosis and intravenous access. The drug will be delivered using
nebulization mask that will last for 15minutes with the help of a wall attached oxygen
driven source (8L, 50psi) according to the respective treatment group.
Heart rate, blood pressure and oxygen saturation will be recorded before and every
3 minutes during nebulization. Presence of bradycardia, hypotension, respiratory
depression, and sedation will be noted.
After 15minutes of nebulization, patient will be shifted to OT and standard ASA monitors
will be attached. Patient will be induced with fentanyl 2 µg/kg, propofol 2 mg/kg and
vecuronium 0.1mg/kg. A Senior Anesthesiologist will perform intubation via direct
laryngoscopy. The ETT cuff will be inflated with air to 20-25 cmH2O pressure with a
sterile single lumen cuffed polyvinyl chloride (PVC) validated with a manometer and
connected to the anesthesia machine. ETT size, laryngoscopy duration and blood on
laryngoscope blade will be documented. Intracuff pressure will be monitored every
30minutes to maintain 20-25 cm H20 pressure. Anaesthesia will be maintained using
33% oxygen in Nitrous oxide and Isoflurane.

Once the surgery is completed, the oropharynx will be gently suctioned using a soft
suction catheter and patient will be assessed for extubation and reversed with IV
Neostigmine 50mcg/kg and IV Glycopyrrolate 10mcg/kg. Data of patients going into
mechanical ventilation post- operative will be excluded from the study.
Ondansetron will be administered to prevent postoperative nausea and vomiting
(PONV)as per the hospital guidelines .
Hemodynamic data will be assessed before intubation, 1 min after intubation, and every
3 min for the first 15 min post-intubation. During surgery, vitals will be recorded every
15 minutes. Following surgery, vitals will be recorded in PACU. Any side effects will be
recorded for 24 hours post extubation. Post operative cough will be graded as follows:
0- No cough of any time since the operation, 1- Minimum,2- Moderate, 3- Severe.
Post operative hoarseness of voice will be graded as follows: 0- No complaint of
hoarseness at any time since the operation,1- Minimal, 2-Moderate,3 - Severe
POST evaluation will be conducted at 0, 2, 6,12, and 24 hours after surgery, utilizing a
four-point scale will be done by a PACU nursing staff who will be oblivious to the group
allocated to the patient
• 0- NIL
• 1- Mild sore throat (sore throat only when asked)
• 2- Moderate sore throat (sore throat even without asking)
• 3- Severe sore throat (change of voice or hoarseness with throat pain).
If moderate or severe POST persists even after 24 hours, lukewarm saline gargle and
decongestants will be started. Whoever has persistent
symptoms, an Oto-rhino-laryngologist consultation will be done.


 
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