A study to see if saline steam inhalation after surgery helps reduce sore throat and breathing discomfort in patients given general anesthesia.

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/06/089168
• Lead Sponsor: Bhaktivedanta Hospital and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-18
• Study Start: 2025-06-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients requiring endotracheal intubation during the procedure.
• Patients who can provide informed consent and comply with study protocols.

Exclusion Criteria

• Patients with a history of chronic respiratory disorders (e.g., asthma, COPD, or recurrent upper respiratory infections).
• All the patients requiring O2 supplementation for more than 30 mins to maintain SpO2 more then 94%.
• Known allergy or hypersensitivity to saline nebulization.
• Patients with pre-existing conditions affecting the pharynx or larynx (e.g., laryngitis, pharyngitis, or vocal cord disorders).
• Emergency surgical cases.
• 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).
• Pregnant or breastfeeding women.
• Patients with a history of smoking within the last 6 months.
• Patients unable to complete postoperative follow-up assessments.
• Patients with significant comorbidities (e.g., uncontrolled diabetes, cardiovascular diseases).
• Any condition or medication that could interfere with the assessment of respiratory or pain symptoms (e.g., sedatives, steroids).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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)
To evaluate its effect on pharyngeal mucosal congestion/hyperaemia

Trial Locations

Locations (1)

Bhaktivedanta Hospital and Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

Bhaktivedanta Hospital and Research Institute

🇮🇳Thane, MAHARASHTRA, India

Dr Vivek Kulkarni

Principal investigator

8928144961

drvivekulkarni2@gmail.com