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CTRI Number  CTRI/2024/12/077963 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two diffrent methods of using drug(Dexamethasone) for reducing sore throat after surgery in patients undergoing general anaesthesia 
Scientific Title of Study   A COMPARITIVE STUDY BETWEEN TOPICAL DEXAMETHASONE AND NEBULIZATION OF DEXAMETHASONE FOR REDUCING POST OPERATIVE SORE THROAT IN PATIENTS UNDERGOING 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  Dr Punitha M N 
Designation  First Year Postgraduate 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department Of Anaesthesiology Navodaya Medical College, Hospital And Research Centre Raichur

Raichur
KARNATAKA
584103
India 
Phone  9901139977  
Fax    
Email  drpunithamn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishalakshi Patil 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department Of Anaesthesiology Navodaya Medical College, Hospital And Research Centre Raichur

Raichur
KARNATAKA
584103
India 
Phone  9986901256  
Fax    
Email  drvishalakshi_patil@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vishalakshi Patil 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre 
Address  Department Of Anaesthesiology Navodaya Medical College, Hospital And Research Centre Raichur

Raichur
KARNATAKA
584103
India 
Phone  9986901256  
Fax    
Email  drvishalakshi_patil@yahoo.co.in  
 
Source of Monetary or Material Support  
Navodaya Medical College , Hospital and Research Centre , Raichur-584013, Karnataka  
 
Primary Sponsor  
Name  Dr Punitha M N 
Address  Department of Anaesthesiology Navodaya Medical College , Hospital And Research Centre , Raichur 584103 
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 Punitha M N  Navodaya Medical College Hospital and Research Centre  Operation Theater, Department of Anaesthesiology, Navodaya Medical College Hospital and Research Centre Raichur 584103
Raichur
KARNATAKA 
9901139977

drpunithamn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instutional Human Ethics Committee(IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H958||Other intraoperative and postprocedural complications and disorders of the ear and mastoid process, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nebulization with Dexamethasone  The patient will be Nebulized with 8mg Dexamethasone (Total Volume 10ml-2ml Dexamethasone and 8ml Normal saline) 30 minutes prior to induction 
Intervention  Topical Dexamethasone  The Endotracheal tube will be pre-treated by dipping in 10ml syringe(After taking out the plunger and blocking the open end) containing Dexamethasone 8mg (Total volume 10ml-2ml Dexamethasone and 8ml Normal saline) 10 minutes prior to intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patient belonging to ASA I and II
2)Mallampati Grading 1 and 2
3)Surgeries lasting for less than 2hours under General Anaesthesia 
 
ExclusionCriteria 
Details  1. Perioperative period
a) Anticipated difficult intubation
b) ASA grading III and IV
c) Previous Upper Airway surgeries
d) Mallampati Grading 3 and 4
e) Upper Respiratory tract infection
f) Chronic obstructive pulmonary disease
g) Patient allergic to study medication
h) Pregnant patients and Patients with history of GERD

2. Intraoperative period
a) More than one laryngoscopic attempts
b) Cormack-Lehane grading 3 and 4
c) Any episode of intraoperative Bronchospasm
d) Any episode of intraoperative Laryngospasm
e) Patient on steroid therapy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess Post Operative Sore Throat   The patient will be assessed for post operative sore throat in 1,6,12,24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess post operative Hoarseness of voice
To assess post operative cough 
The patient will be assessed for post operative hoarseness of voice and post operative cough in 1,6,12,24 hours after surgery 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   30/12/2024 
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 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 - NO
Brief Summary  
As approval from Institutional Human Ethical Committee has been obtained, written and informed consent will be taken from the patients undergoing surgery. Those satisfying the inclusion and exclusion criteria are randomly allocated using a computer-generated random number table to any of the two groups. 
        
 GROUP ‘N’: Nebulization with Dexamethasone 8mg in 10ml
 GROUP ‘T’: Topical Dexamethasone 8mg in 10ml
             All the patients will undergo pre-anaesthetic evaluation which includes detailed history taking, physical examination and necessary investigations like complete blood count, blood urea, serum creatinine, HIV, HBsAg etc.  
             Tab Alprazolam 0.5mg and Cap Pantoprazole 40mg are given orally at night on the day before surgery. All the patients are kept nil per oral as per standard guidelines.

GROUP ‘N’:
Patient will be shifted to pre-operative room. Intravenous line will be secured. The patient will be nebulized with 8mg Dexamethasone [total volume 10ml- 2ml dexamethasone with 8ml normal saline] 30 minutes prior to induction. Patient will be shifted to operation theatre and standard ASA monitors will be connected. Preoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, electrocardiogram are recorded and appropriate intravenous fluid is started. Patient will be preoxygenated with 100% oxygen for 3minutes and pre-medications will given, induced with Propofol(2mg/kg) and Atracurium(0.5mg/kg). Patient will be intubated with appropriate sized single use disposable large volume low pressure cuffed endotracheal tube.


GROUP ‘T’
Patient will be shifted to pre-operative room. Intravenous line will be secured. Patient will be shifted to operation theatre and standard ASA monitors will be connected. Preoperative systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, respiratory rate, oxygen saturation, electrocardiogram are recorded and appropriate intravenous fluid is started. The endotracheal tube will be pre-treated by dipping in 10ml syringe (after taking out the plunger and blocking the open end) containing Dexamethasone 8mg [total volume 10ml- 2ml dexamethasone with 8ml normal saline] 10 minutes prior to intubation. Patient will be preoxygenated with 100% oxygen for 3minutes and pre-medications will be given, induced with Propofol(2mg/kg) and Atracurium(0.5mg/kg). Patient will be intubated with appropriate sized single use disposable large volume low pressure cuffed endotracheal tube.
                     

  In both the groups – Group N and Group T Cormack-Lehane grading will be noted in all patients during laryngoscopy. The cuff will be inflated with room air and cuff pressure kept around 20-25cm of water. The endotracheal tube placement will be confirmed with end-tidal carbon-dioxide concentration. Anaesthesia will be maintained on 66%:33% - N2O:O2. Cuff pressure will be monitored with cuff manometer every 15 minutes and after change in patient’s position and pressure will be kept in between 20-25cm of water. Paracetamol infusion and Ondansetron will be given intravenously for post operative pain relief and post operative nausea and vomiting. Gentle suctioning will be done and spontaneous efforts of breathing will be checked. Reversal agent-Glycopyrrolate and Neostigmine will be given when patients are able to obey verbal commands and when ventilation was considered adequate, extubation will be done.
Patients will be assessed for Sore Throat, Hoarseness of voice and Cough in 1, 6, 12, 24 hours of post-operative period.
 
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