| CTRI Number |
CTRI/2026/01/102319 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Three Nebulised Medicines To Prevent Sore Throat After Breathing Tube Placement During Surgery |
|
Scientific Title of Study
|
Comparative Study Of Nebulised Dexmedetomidine Dexamethasone And Lignocaine For Prevention Of Post Operative Sore Throat Following Endotracheal Intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi |
| Designation |
post graduate resident |
| Affiliation |
govt multispecialty hospital hospital sector 16 , chandigarh |
| Address |
Room no 407 ,Department of Anaesthesia ,Government Multi Specialty Hospital Sector16 Chandigarh 160015
Chandigarh
CHANDIGARH
160015
India |
| Phone |
09465274461 |
| Fax |
|
| Email |
pallavibissarwal@Gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parmjit Singh |
| Designation |
DMS and Guide |
| Affiliation |
govt multispecialty hospital hospital ,sector 16 , chandigarh |
| Address |
Room no 407, Department of Anaesthesia, Government Multi Specialty Hospital Sector16 Chandigarh 160015
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9814008099 |
| Fax |
|
| Email |
gmsh.dms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anshul |
| Designation |
MO and Coguide |
| Affiliation |
govt multispecialty hospital hospital ,sector 16 , chandigarh |
| Address |
Room no 407, Department of anaesthesia, Government Multi Specialty Hospital, Sector 16,Chandigarh 160015
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9872027804 |
| Fax |
|
| Email |
anshulssachdeva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Multispecialty Hospital Sector16 Chandigarh, India ,160015 |
|
|
Primary Sponsor
|
| Name |
Govt Multispeciality Hospital |
| Address |
Govt Multispecialty Sector 16 Chandigarh 160015 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Govt Multi Speciality hospital |
Sector 16, Chandigarh, 160015 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pallavi |
Govt Multispecialty Hospital Sector 16 Chandigarh |
Department of Anaesthesia, OT Complex, Govt Multispecialty Hospital Sector 16 Chandigarh 160015
Chandigarh
CHANDIGARH |
9465274461
pallavibissarwal@Gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
| Comparator Agent |
Dexamethasone |
Patient will receive Nebulisation with Dexamethasone 8mg |
| Comparator Agent |
Dexmedetomidine |
Patient will receive Nebulisation with Dexmedetomidine 50mcg |
| Comparator Agent |
Lignocaine |
Patient will receive Nebulisation with Lignocaine 4 percent 80mg |
| Intervention |
Nebulisation |
patient will Receive Nebulisation preoperatively for 10 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent for the study
Patients with ASA Grade I And II
Patients with MPG I And II
BMI less than 29.5 Kg Per Meter square
Single Intubation attempt (less than 20 sec)
|
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Head and Neck surgeries
History of recent upper respiratory tract infection or sore throat
patient allergic to drugs used in study
Duration of surgery more than 3 Hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Incidence and Severity of Post Operative Sore Throat
To Compare the Post Operative Sore Throat Scores |
At Extubation Zero hour three hour six hour twelve hour and twenty four hour Post Operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note any side effect |
During Nebulisation During Intubation and in Post Operative Period |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/02/2026 |
| 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
|
This Study Is prospective randomized double blind study conducted to evaluate the effectiveness of Nebulised Dexmedetomidine Dexamethasone and Lignocaine for prevention of post operative sore throat following endotracheal intubation under general anaesthesia. Adult patients undergoing elective surgery under general anaesthesia with endotracheal intubation will be randomly allocated into three groups to receive preoperative Nebulisation with one of the study drugs. The Primary objective is to compare the incidence and severity of postoperative sore throat .and to compare post operative sore throat scores. Secondary objective is to not any side effect. |