An interventional study of Nebulized 0.9% Normal Saline and Water-Soluble Lubricant Gel on Endotracheal Tube in Postoperative Sore Throat, Nasal Obstruction and Septoplasty, sponsored by Mansoura University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Mansoura University · Not applicable, Interventional, and Prevention
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.
BACKGROUND:
Existing literature on POST in nasal surgery treats all septoplasty patients as homogeneous, regardless of nasal obstruction severity. Patients with severe obstruction (NOSE score ≥55) are chronic mouth-breathers who bypass normal nasal air humidification, producing measurable pharyngeal mucosal dehydration, epithelial thinning, and chronic dry inflammation - a pre-existing vulnerability amplified by intubation and throat pack placement.
INTERVENTION:
Group A (Intervention): Nebulized 0.9% NaCl (5 mL, 15 min via compressor jet nebulizer, particle size 2-5 µm) administered 30 minutes pre-induction with patient breathing through mouth; plus water-soluble lubricant gel (K-Y Jelly or equivalent) applied to ETT cuff and distal 5 cm.
Group B (Control): Sham nebulization (room air, identical device and duration); ETT lubricated with plain water only.
STANDARDIZED PROTOCOL (both groups):
Induction: propofol 1.5-2 mg/kg + fentanyl 1-2 µg/kg + rocuronium 0.6 mg/kg. Maintenance: sevoflurane 1.0-1.5 MAC in O2/Air (no nitrous oxide). ETT cuff maintained at 20-25 cmH2O (checked every 30 minutes by calibrated aneroid manometer). Standardized saline-soaked throat pack for all patients. Awake extubation with single gentle suction.
NOVEL ELEMENTS:
RANDOMIZATION AND BLINDING:
Computer-generated block randomization (variable blocks of 4 and 6), stratified by NOSE severity (55-75 vs 80-100). Allocation concealed via sequentially numbered opaque sealed envelopes. Outcome assessor and patient blinded; anesthesiologist not blinded but is not the outcome assessor.
SAMPLE SIZE:
n=105 (52-53/group); 80% power; two-sided alpha=0.05; anticipated 65% POST incidence in control group; clinically meaningful absolute reduction of 35%; 15% dropout allowance.
111 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's planned enrollment of 105 is above the median of 52 across 82 interventional studies indexed under Nasal Obstruction.
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Exclusion Criteria:
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.
Device: Nebulized 0.9% Normal Saline · Device: Water-Soluble Lubricant Gel on Endotracheal Tube
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.
Device: Sham Nebulization
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.
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.
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.
Time frame: 1 hour after extubation
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.
Time frame: 1 hour, 6 hours, and 24 hours post-extubation
Incidence and Severity of Hoarseness
1 hour, 6 hours, and 24 hours post-extubation
Time frame: Hoarseness graded 0-3 (0=none; 1=mild/perceived only; 2=moderate/noticed by others; 3=severe/aphonia).
Incidence and Severity of Dysphagia
Dysphagia graded 0-3 (0=none; 1=mild; 2=moderate/significant difficulty; 3=severe/unable to swallow).
Time frame: 1 hour and 6 hours post-extubation
Incidence of Postoperative Nausea and Vomiting
Time frame: 6 hours and 24 hours post-extubation
Time to First Analgesic Request for Throat Pain
Time in minutes from extubation to first patient-initiated request for analgesia specifically for throat pain.
Time frame: From extubation to 24 hours post-extubation
Preoperative Pharyngeal Mucosal Hydration
Mucosal hydration measured by patient VAS dryness score (0-10). Measured before and after nebulization to confirm intervention effect.
Time frame: Before and after nebulization/sham, approximately 30-40 minutes pre-induction
Patient Satisfaction with Recovery
Numerical Rating Scale 0-10 (0=completely unsatisfied, 10=completely satisfied).
Time frame: 24 hours post-extubation
Dose-Response Correlation - NOSE Score and POST Severity
Exploratory Pearson/Spearman correlation between preoperative NOSE score (continuous variable) and POST VAS across both groups
Time frame: 24 hours (pooled data)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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