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

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. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089168
Enrollment
50
Registered
2025-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 surge

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Monitored postoperatively at specific time points (6 hours, 12 hours, and 24 hours)

Secondary

MeasureTime frame
To evaluate its effect on pharyngeal mucosal congestion/hyperaemia Timepoint: 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.Timepoint: Monitored postoperatively at specific time points (6 hours, 12 hours, and 24 hours)

Countries

India

Contacts

Public ContactDr Vivek Kulkarni

Bhaktivedanta Hospital and Research Institute

drvivekulkarni2@gmail.com8928144961

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026