| CTRI Number |
CTRI/2025/10/096565 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the drugs Ropivacaine and Dexmedetomidine nebulization in preventing sore throat after surgeries. |
|
Scientific Title of Study
|
A comparative study of nebulised ropivacaine and dexmedetomidine in the prevention of postoperative sore throat following general anaesthesia : A prospective study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavani I Kolhar |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9482693865 |
| Fax |
|
| Email |
bhavanikolhar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Basappa Hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
8310268837 |
| Fax |
|
| Email |
vinodhosallidr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Basappa Hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology,
ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
8310268837 |
| Fax |
|
| Email |
vinodhosallidr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,
Sapthagiri Institute of Medical Sciences and Research Centre, 15 Hesarghatta road, Navy Layout,AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, 15Hesarghatta road, Navy Layout,AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
| Type of Sponsor |
Private 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 Bhavani I Kolhar |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology,
ground floor, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesarghatta Main Road, Chikkabanavara, Bangalore
Bangalore
KARNATAKA |
09482693865
bhavanikolhar3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre |
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 |
Comparing nebulized Ropivacaine and Dexmedetomidine |
Out of 60 patients, 30 will receive nebulized Dexmedetomidine 50 mcg (0.5 mL) with 4.5 mL of saline, and the other 30 will receive nebulized Ropivacaine 0.75% 5 mL, just 30 minutes before induction, as per group allocation in the preoperative room. |
| Intervention |
Nebulization with Dexmedetomidine 50 mcg (0.5 mL) with 4.5 mL normal saline will be given to group D and nebulization Ropivacaine 0.75% 5 mL in group R. |
Nebulization will be given in the preoperative room 30 minutes before induction, as per the group allocation, and postoperative sore throat evaluation will be conducted at 1,2, 4, 6,12, and 24 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent
American Society of Anaesthesiology physical status I and II
Age between 18 to 60 years
Airway assessment by Mallampati grade I and II
Patients undergoing elective surgeries under general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Duration of surgery is more than 3 hrs
Cardiopulmonary comorbidities
Patients receiving corticosteroids
Pre-existing pharyngeal laryngeal disease and sore throat |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of nebulised Ropivacaine and nebulised Dexmedetomidine in preventing postoperative sore throat following intubation in patients undergoing general anaesthesia.
To compare the efficacy of nebulised ropivacaine and nebulised dexmedetomidine on the haemodynamic response before and after intubation.
To compare incidence of side effects of nebulised ropivacaine and nebulised dexmedetomidine postoperatively in patients undergoing general anaesthesia. |
Postoperative sore throat will be assessed at 1,2,4,6,12 and 24 hours after surgery.
Haemodynamic data will be assessed before nebulisation, after nebulisation, before tracheal intubation, after intubation, 5 minutes after intubation, at closure of skin incision, immediately after extubation, 5 minutes after extubation.
All adverse events occurring during the postoperative period related to the use of nebulised ropivacaine and dexmedetomidine will be assessed for the next 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/11/2025 |
| 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 is a prospective study comparing the efficacy of nebulized Ropivacaine and nebulized Dexmedetomidine in preventing postoperative sore throat following intubation in patients undergoing general surgery, it compares the efficacy of nebulized Ropivacaine and nebulized Dexmedetomidine on the haemodynamic response before and after intubation and also compares the incidence of side effects of nebulized Ropivacaine and nebulized Dexmedetomidine postoperatively in patients. Patients fulfilling the inclusion criteria will be randomly divided into two groups of 30 each. Group D will be nebulized with Dexmedetomidine 50 mcq (0.5 mL) along with 4.5 mL of saline, totalling 5 mL and Group R will be nebulized with Ropivacaine 0.75% 5 mL. Nebulization will be given in the preoperative room 30 minutes before induction as per the group allocation. Postoperative sore throat will be assessed at 1,2,4,6,12, and 24 hrs after surgery. Haemodynamic data like pulse rate, heart rate and blood pressure will be assessed before nebulization, after nebulization, before tracheal intubation, after tracheal intubation, 5 minutes after tracheal intubation, at the closure of skin incision, immediately after tracheal extubation, and 5 minutes after tracheal extubation. All adverse events occurring during the postoperative period related to the use of nebulized Ropivacaine and nebulized Dexmedetomidine will be recorded.
|