CTRI Number |
CTRI/2022/08/044924 [Registered on: 25/08/2022] Trial Registered Prospectively |
Last Modified On: |
31/08/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Sore throat after surgery |
Scientific Title of Study
|
Comparison of topical Betamethasone gel and Nebulised Dexamethasone in attenuating Post Operative Sore Throat in patients undergoing Surgeries under General Anaesthesia- a randomized controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr CH Rama Krishna Prasad |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad Hyderabad TELANGANA 500004 India |
Phone |
09885718133 |
Fax |
|
Email |
ramakrishna.chikkala19@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr CH Rama Krishna Prasad |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad Hyderabad TELANGANA 500004 India |
Phone |
09885718133 |
Fax |
|
Email |
ramakrishna.chikkala19@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr CH Rama Krishna Prasad |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad Hyderabad TELANGANA 500004 India |
Phone |
09885718133 |
Fax |
|
Email |
ramakrishna.chikkala19@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences |
Address |
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
|
Type of Sponsor |
Research institution and hospital |
|
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 |
CH RAMA KRISHNA PRASAD |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Room no- 49, A block, ground floor,
All India Institute of Medical Sciences, bobinagar, Hyderabad, 508126
Hyderabad TELANGANA |
09885718133
ramakrishna.chikkala19@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Betamethasone |
Betamethasone 0.05% TOPICAL ( over the endotracheal tube)
sore throat and cough after topical betamethasone applied on ET tube |
Comparator Agent |
Dexamethsone |
Dexamethsone 8 mg 5 minutes before surgery via Nebulisation once
sore thorat and cough after giving nebulised dexamethasone |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with ages between 18-60 years
ASA Physical Status of 1 & 2
Patients undergoing elective procedures under general anaesthesia with expected surgical duration below 6 hours
|
|
ExclusionCriteria |
Details |
Pre existing sore throat/ hoarseness on pre op assessment
Recent lower respiratory tract infection
Known hypersensitivity to steroids
Procedure more than 6 hours
Oral and neck surgeries
Pregnant patients
Patients with cognitive disabilities
Patients requiring NG tube insertion
Patients requiring Rapid Sequence Induction, Intubation
Patients requiring use of Succinyl Choline for neuromuscular blockade
Difficult intubation
Use of additional gadgets such as bougie, stylets for aiding in intubation
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Sore throat |
at 4 hours,8 hours , 12 hours,24 hours and 48 hours after extubation |
|
Secondary Outcome
|
Outcome |
TimePoints |
cough |
at 4 hours, 8 hours,12 hours,24 hours,48 hours after extubation |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
31/08/2022 |
Date of Study Completion (India) |
31/08/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Though Post Operative Sore throat is a
minor complication after General Anaesthesia, but it poses immense discomfort
to the patient.It leads to cough which may cause strain at the suture site
eventually effects the healing. In this era of day care surgery and enhanced
recovery of the patients after the surgery, patient should be able to return to
his/her routine activity without any discomfort/limitation as early as
possible. Though considered as a minor complication by many clinicians,sore
throat/hoarseness/cough in the post operative period poses high risk of patient
discomfort and dissatisfaction after the surgery. Total incidence of post
operative sore throat is around 68%.Various pharmacological and non
pharmacological methods were tried with variable success rate.The underlying
cause for POST might be trauma to the oropharynx, base of tongue, or posterior
pharyngeal wall or inflammationsecondary to trauma caused by airway device
used. Trauma to epithelial layer or deeper layers of vocal cords may initiate
inflammation leading to edema. Anti inflammatory drugs will be effective in
countering the inflammation caused by the trauma to the airway/ mucosa. Steroids
are one such group of drugs which help in reducing the inflammation caused by
the initial insult/trauma. Hence usage of steroids in various formulations and
various routes were tried to attenuate the initial inflammation caused due to
endo tracheal intubation in the airway mucosa eventually hypothecating that
there would be reduction in incidence of post operative sore throat.Steroids
reduce the production of inflammatory mediators, prostaglandins, and leukotrienes.
The mechanism behind this is inhibition of phospholipase-A2 through production
of calcium-dependent phospholipid-binding proteins known as annex-ins and cyclo-oxygenase.
Hence, the efficacy of two highly potent steroids betamethasone and dexamethasone
given topical and nebulised forms respectively prior to intubationis compared
in reduction of incidence of POST.There is a limited literature available in
testing the efficacy of highly potent topical betamethasone preparation when applied
to the Endotracheal tube. So, we attempted to study the efficacy of topical
Betamethasone gel when compared with nebulised dexamethasone in reducing the
incidence of post operative sore throat. |