| 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
|
|
|
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
|
|
|
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. |