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NOT YET RECRUITING
NCT07870252
NA

Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction: A Double-Blind RCT

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

Postoperative sore throat (POST) affects 21-65% of patients after endotracheal intubation and is among the most common complaints after general anesthesia. Patients presenting for septoplasty with severe nasal obstruction (NOSE score ≥55) are habitual chronic mouth-breathers, having bypassed nasal air conditioning for months to years preoperatively. This produces a documented state of pharyngeal mucosal dehydration and inflammation that precedes any surgical event - making these patients a distinct high-risk subgroup for POST that has never been identified or studied. This double-blind RCT will test whether a simple, low-cost multimodal pharyngeal mucosal conditioning strategy - nebulized 0.9% normal saline (5 mL over 15 minutes, 30 minutes before induction) combined with a water-soluble lubricant gel applied to the endotracheal tube - reduces POST incidence and severity compared to standard care (sham nebulization plus plain water on the ETT). 105 adults aged 18-60 years with NOSE score ≥55 scheduled for elective septoplasty under general anesthesia will be randomized 1:1. The primary outcome is POST incidence at 1 hour post-extubation assessed by a blinded PACU nurse. Secondary outcomes include POST severity (VAS 0-10) at 1h, 6h, and 24h; hoarseness; dysphagia; PONV; time to first analgesic; and preoperative pharyngeal mucosal hydration measured by the Modified Schirmer Test.

Official title: Multimodal Pharyngeal Mucosal Conditioning Versus Standard Care for Prevention of Postoperative Sore Throat in Septoplasty Patients With Severe Preoperative Nasal Obstruction: A Double-Blind Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2026-10-15

Completion Date

2027-04-30

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DEVICE

Nebulized 0.9% Normal Saline

0.9% Normal saline 5 mL nebulized over 15 minutes via compressor jet nebulizer (target particle size 2-5 µm) administered 30 minutes before anesthetic induction, with patient breathing normally through the mouth to maximize pharyngeal deposition.

DEVICE

Water-Soluble Lubricant Gel on Endotracheal Tube

Water-soluble lubricant gel (K-Y Jelly or bioequivalent) applied uniformly to the ETT cuff outer surface and distal 5 cm of the ETT shaft immediately before endotracheal intubation.

DEVICE

Sham Nebulization

Identical compressor nebulizer device delivering room air only, operated for 15 minutes. Device produces the same sound and airflow as the active nebulizer. No saline delivered.

Locations (1)

Qassim University Medical City

Buraidah, Al-Qassim Region, Saudi Arabia