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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind study enrolling adults with severe nasal obstruction undergoing septoplasty. It compares preoperative nebulized saline plus endotracheal tube lubrication versus sham nebulization with plain lubrication to see if POST is reduced. All participants receive a standardized anesthesia protocol and throat care, with outcomes focused on the incidence and severity of postoperative sore throat. The study targets patients with NOSE scores ≥55 to identify a high-risk subgroup for POST and to explore a simple, low-cost mucosal conditioning approach. Primary results will inform whether this conditioning strategy should be adopted more broadly in nasal obstruction patients undergoing airway instrumentation.

Why it matters

Who can join: the full rules

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

Where it's running

• Qassim University Medical City
  Buraidah, Al-Qassim Region, Saudi Arabia Recruiting

Study contacts

• Principal investigator: Mohamed Ahmed Tolba, MD — Mansoura University - Qassim University Medical City
• Study coordinator: Mohamed Ahmed Tolba, MD
• Email: m_atolba1234@mans.edu.eg
• Phone: 00966507439018

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.