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CTRI Number  CTRI/2025/06/089168 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see if saline steam inhalation after surgery helps reduce sore throat and breathing discomfort in patients given general anesthesia. 
Scientific Title of Study   A single-center, prospective, interventional, randomized, two-arm, comparative pilot study to evaluate the effect of post-operative saline nebulization on upper respiratory dysfunction in patients undergoing general anesthesia. 
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 Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  8928144961  
Fax    
Email  drvivekulkarni2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  8928144961  
Fax    
Email  drvivekulkarni2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  8928144961  
Fax    
Email  drvivekulkarni2@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107. 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Kulkarni   Bhaktivedanta Hospital and Research Institute  Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 		 8928144961

drvivekulkarni2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulization with isotonic saline 5 mL  Patients in the intervention group will receive nebulization with 5 mL isotonic saline in the recovery area between 30 to 45 mins after the surgery. 
Comparator Agent  Standard of care  Patients in the control group will receive standard postoperative care as practiced in the tertiary healthcare facility. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients requiring endotracheal intubation during the procedure.
2. Patients who can provide informed consent and comply with study protocols.
3. ASA (American Society of Anaesthesiologists) physical status I–III.
 
 
ExclusionCriteria 
Details  1. Patients with a history of chronic respiratory disorders (e.g., asthma, COPD, or recurrent upper respiratory infections).
2. All the patients requiring O2 supplementation for more than 30 mins to maintain SpO2 more then 94%.
3. Known allergy or hypersensitivity to saline nebulization.
4. Patients with pre-existing conditions affecting the pharynx or larynx (e.g., laryngitis, pharyngitis, or vocal cord disorders).
5. Emergency surgical cases.
6. Patient unable to sit upright for receiving nebukization therapy because of any medical or surgical condition (including spine surgery, hip surgery, etc not limited laparotomy).
7. Pregnant or breastfeeding women.
8. Patients with a history of smoking within the last 6 months.
9. Patients unable to complete postoperative follow-up assessments.
10. Patients with significant comorbidities (e.g., uncontrolled diabetes, cardiovascular diseases).
11. Any condition or medication that could interfere with the assessment of respiratory or pain symptoms (e.g., sedatives, steroids).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of post-operative saline nebulization in upper respiratory dysfunction, including symptoms such as hoarseness of voice, sore throat, cough, thirst, dysgeusia (altered taste) and hyposmia (reduced smell) in patients undergoing general anaesthesia.  Monitored postoperatively at specific time points (6 hours, 12 hours, and 24 hours) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate its effect on pharyngeal mucosal congestion/hyperaemia
 		 Monitored postoperatively at specific time points (6 hours, 12 hours, and 24 hours) 
To compare the overall recovery experience and adverse effects, if any, between the two study groups.  Monitored postoperatively at specific time points (6 hours, 12 hours, and 24 hours) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/06/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 single-center, prospective, interventional, randomized, two-arm comparative pilot study aims to evaluate the effect of post-operative saline nebulization on upper respiratory dysfunction in patients undergoing general anesthesia with endotracheal intubation. The rationale stems from the high incidence of post-operative sore throat (POST) and related symptoms, which can impact patient comfort and recovery. The study will enroll 50 adult patients (aged 18–65 years) undergoing elective surgeries under general anesthesia, randomized into two groups: one receiving 5 mL isotonic saline nebulization postoperatively and the other receiving standard care. Inclusion criteria include ASA physical status I–III, while exclusions cover chronic respiratory conditions, recent smoking, and inability to comply with follow-up. The intervention will be administered 30–45 minutes post-surgery, and outcomes will be assessed at 6, 12, and 24 hours postoperatively. The primary objective is to assess the reduction in symptoms such as sore throat, hoarseness, cough, dysgeusia, and hyposmia using a severity grading scale. Secondary objectives include evaluating pharyngeal mucosal congestion/hyperaemia and comparing overall recovery and adverse effects. The study duration is two years, and as it involves a non-drug intervention, it is classified as a pilot study with no formal trial phase designation. Expected outcomes include improved postoperative respiratory comfort and reduced symptom severity in the intervention group. 
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