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POST-MUCOSAL R
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
Sponsor study identifier
Secondary identifiers
OTHER · Qassim University Bioethics IRB
interventional
105
1 country
1
Study Start
October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2026
Actual (reported)October 13, 2026
Actual (reported)October 15, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
1 hour after extubation
POST Severity - Visual Analogue Scale
1 hour, 6 hours, and 24 hours post-extubation
Incidence and Severity of Hoarseness
Hoarseness graded 0-3 (0=none; 1=mild/perceived only; 2=moderate/noticed by others; 3=severe/aphonia).
Nebulized 0.9% normal saline (5 mL over 15 minutes via compressor jet nebulizer, particle size 2-5 µm) administered 30 minutes before anesthetic induction with patient breathing through the mouth; followed by water-soluble lubricant gel (K-Y Jelly or equivalent) applied uniformly to the ETT cuff and distal 5 cm immediately before intubation.
Sham nebulization using an identical compressor device delivering room air only (15 minutes, same duration and posture as active arm); ETT lubricated with plain water only - current institutional standard practice.
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.
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.
Qassim University Medical City
Buraidah, Al-Qassim Region, 51452, Saudi Arabia
Mohamed Ahmed Tolba, MD
Mansoura University - Qassim University Medical City
First Submitted
October 6, 2026
First Posted
October 13, 2026
Study Start
October 15, 2026
Estimated (date passed)Incidence and Severity of Dysphagia
1 hour and 6 hours post-extubation
Incidence of Postoperative Nausea and Vomiting
6 hours and 24 hours post-extubation
Time to First Analgesic Request for Throat Pain
From extubation to 24 hours post-extubation
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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 15, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 15, 2026
Record last verified: 2026-10
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