| CTRI Number |
CTRI/2023/11/060109 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of the drug dexamethasone and lidocaine when used before surgery as inhalation to prevent post operative sore throat |
|
Scientific Title of Study
|
A study to evaluate the efficacy of nebulization with Dexamthasone and Lidocaine preoperatively on post operative sore throat(POST) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Johar |
| Designation |
Professor |
| Affiliation |
PT. BDS university of health sciences Rohtak |
| Address |
Department of Anaesthesiology PGIMS rohtak
Haryana
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9416050652 |
| Fax |
|
| Email |
sanjays321@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Dayora |
| Designation |
Postgraduate student |
| Affiliation |
PT. BDS university of health sciences Rohtak |
| Address |
Department of Anaesthesiology and Critical care PGIMS rohtak
Haryana
124001
India
Rohtak
HARYANA
124001
India |
| Phone |
9991540213 |
| Fax |
|
| Email |
rahulprazapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Dayora |
| Designation |
Postgraduate student |
| Affiliation |
PT. BDS university of health sciences Rohtak |
| Address |
Department of Anaesthesiology and Critical care PGIMS rohtak
Haryana
124001
India
HARYANA
124001
India |
| Phone |
9991540213 |
| Fax |
|
| Email |
rahulprazapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology PT. BDS Pgims Rohtak
Haryana
124001
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology
PT BDS PGIMS Rohtak |
| Type of Sponsor |
Government medical college |
|
|
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 Rahul Dayora |
PT. BDS PGIMS Rohtak |
Department of Anaesthesiology
Modular OT building 2nd floor
Rohtak
HARYANA |
9991540213
rahulprazapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt BDS Pgims Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y838||Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone 8mg
Lidocaine 4%
Normal Saline 5ml |
Two groups of patients will be nebulized via inhalational route with Dexamethasone 8mg and Lidocaine 4% (80mg) each and one with normal saline as control group. The medications will be made upto 5ml with sterile water and delivered with nebulizer for 10min. During nebulization patients will be inclined at 45 degree and encouraged to simultaneously breathe through the mouth and nose |
| Comparator Agent |
Dexamethasone vs Lidocaine |
Two groups of patients will be nebulized via inhalational route with Dexamethasone 8mg and Lidocaine 4% (80mg) each and one with normal saline as control group. The medications will be made upto 5ml with sterile water and delivered with nebulizer for 10min. During nebulization patients will be inclined at 45 degree and encouraged to simultaneously breathe through the mouth and nose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of ASA physical status I and II, age between 18 and 60 years of either sex, undergoing elective surgeries in supine position under General Anaesthesia with endotracheal intubation lasting < 3 hours will be enrolled in the study
|
|
| ExclusionCriteria |
| Details |
Patients with recent sore throat(<14days)
Patients with history of recent(<14days) use of steroids or NSAIDS.
Pregnant patients.
Patients with present chronic airway disease.
Anticipated difficult airway.
Patients undergoing head and neck procedures.
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The incidence of Postoperative sore throat at 4 hours post extubation |
The incidence of Postoperative sore throat at 4 hours post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidences & severities observed at 2 4 8 12 & 24 hours post surgery on a four point scale for
Any hoarseness of voice |
0 no hoarseness
1 mild hoarseness
2 moderate hoarseness
3 severe hoarseness |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "135"
Final Enrollment numbers achieved (India)="135" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2023 |
| Date of Study Completion (India) |
01/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Postoperative sore
throat (POST) is a common adverse
event after general anesthesia especially with endotracheal intubation.
Reported incidence of POST following general anesthesia is variable and ranges
between 20-74%[1]. Aetiology is multifactorial which includes
patient-related factors such as age, sex, smoking; and intubation factors
including technique, duration, number of attempts, tube size,
intracuffpressure, cuff design, intraoperative tube movement, airway
manipulations, and suctioning[2]. Mucosal damage by mechanical injury
due to airway manipulation and dehydration of the orophyrangeal mucosa are
considered to result in post-operative sore throat . Postoperative sore
throat (POST) is a common adverse
event after general anesthesia especially with endotracheal intubation.
Reported incidence of POST following general anesthesia is variable and ranges
between 20-74%[1]. Aetiology is multifactorial which includes
patient-related factors such as age, sex, smoking; and intubation factors
including technique, duration, number of attempts, tube size,
intracuffpressure, cuff design, intraoperative tube movement, airway
manipulations, andsuctioning[2]. Mucosal damage by mechanical injury
due to airway manipulation and dehydration of the orophyrangeal mucosa are
considered to result in post-operative sore throatPostoperative sore
throat (POST) is a common adverse
event after general anesthesia especially with endotracheal intubation.
Reported incidence of POST following general anesthesia is variable and ranges
between 20-74%[1]. Aetiology is multifactorial which includes
patient-related factors such as age, sex, smoking; and intubation factors
including technique, duration, number of attempts, tube size,
intracuffpressure, cuff design, intraoperative tube movement, airway
manipulations, and suctioning[2]. Mucosal damage by mechanical injury
due to airway manipulation and dehydration of the orophyrangeal mucosa are
considered to result in post-operative sore throat. Pharmacological measures for attenuating
POST include use of topical, intravenous or inhalational agents.Various
pharmacological agents such as ketamine,
benzydamine hydrochloride, lignocaine, magnesium and corticosteroids are used
to prevent POST. Locally used agents reduce airway inflammation by active
anti-inflammatory and analgesic properties when used preemptively and have
minimal systemic side effects. In recent years
nebulization with different drugs for POST have been used preoperatively and
studies have shown a reduction in the incidence and severity of POST. Due to
sparing of bitter taste nebulization are better accepted and tolerated by the
patients. Requirement of small volume of drugs for effect, easy way of
administration, better patient compliance, and very less risk of adverse events
makes nebulization therapy preferred choice over other methods such as gargle,
intravenous etc |