Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction

Study acronym: POST-MUCOSAL R
StatusNot Yet Recruiting
PhaseNot applicable
Started

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  1. Minor Study title shortened, about 3 words
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07870252
Lead Sponsor Mansoura University
Conditions
(from sponsor)
Postoperative Sore Throat, Nasal Obstruction, Septoplasty
Related terms Nasal Obstruction
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov