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.
Age 18 to 60 years
ASA physical status I or II
NOSE score ≥55 (severe or extreme nasal obstruction category) at preoperative assessment
Duration of nasal obstruction symptoms ≥6 months
Current or past smoker (any amount)
Gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR)
Known pharyngeal or laryngeal pathology
Active upper respiratory tract infection within 2 weeks of scheduled surgery
Parallel
Nebulized 0.9% Normal Saline
Device0.9% 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.
Water-Soluble Lubricant Gel on Endotracheal Tube
DeviceWater-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.
Sham Nebulization
DeviceIdentical 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.
Incidence of Postoperative Sore Throat (POST) at 1 Hour Post-Extubation
POST assessed by a blinded PACU nurse using a validated 4-point categorical scale: 0 = no sore throat; 1 = mild (only on direct questioning, no analgesic required); 2 = moderate (spontaneous complaint, non-opioid analgesic given); 3 = severe (spontaneous complaint, opioid analgesic required). POST is considered present if score ≥1.
POST Severity - Visual Analogue Scale
POST severity scored on VAS 0-10 (0=no pain, 10=worst imaginable pain) by blinded assessor at 1h, 6h, and 24h.
Incidence and Severity of Hoarseness
1 hour, 6 hours, and 24 hours post-extubation
Incidence and Severity of Dysphagia
Dysphagia graded 0-3 (0=none; 1=mild; 2=moderate/significant difficulty; 3=severe/unable to swallow).
Incidence of Postoperative Nausea and Vomiting
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