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NCT07870252
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction: A Double-Blind RCT
Conditions: Postoperative Sore Throat, Nasal Obstruction, Septoplasty
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 105
Sponsor: Mansoura University
Location: Qassim University Medical City Buraidah Al-Qassim Region
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.
Eligibility Criteria
Inclusion Criteria:
* 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
* Scheduled for elective septoplasty ± turbinoplasty under general anesthesia with endotracheal intubation
* Mallampati class I or II
* BMI ≤35 kg/m²
* Written informed consent obtained
Exclusion Criteria:
* 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
* Preoperative sore throat or baseline pharyngeal pain at time of assessment
* Anticipated difficult airway (Mallampati class III-IV, mouth opening less than 3 cm)
* ACE inhibitor use (causes dry cough, confounds POST assessment)
* Concurrent tonsillectomy, adenoidectomy, or rhinoplasty extending operative time beyond 90 minutes
* Known allergy to lubricant gel components
* Severe systemic disease affecting mucosal hydration (Sjögren's syndrome, uncontrolled diabetes mellitus, end-stage renal disease)
* Pregnancy or breastfeeding
* Previous participation in this study
Source: ClinicalTrials.gov (NCT07870252). StuddyBuddy aggregates publicly available trial information.