Postoperative Sore ThroatPOST-MUCOSAL RNCT07870252
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
A study testing Nebulized 0.9% Normal Saline and Water-Soluble Lubricant Gel on Endotracheal Tube in people with Postoperative Sore Throat and Nasal Obstruction, run by Mansoura University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Sore Throat, Nasal Obstruction, Septoplasty
- What is being tested?
- Nebulized 0.9% Normal Saline and Water-Soluble Lubricant Gel on Endotracheal Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2026to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Qassim University Medical City
Buraidah, Al-Qassim Region, 51452
Mohammed Ahmed Ahmed Tolba, MD, 00966507439018, m_atolba1234@mans.edu.eg
About this study
Official title: 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
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.
Read the detailed description
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:
- First RCT to enroll nasal surgery patients specifically by NOSE score severity
- First study to test preoperative mucosal conditioning as a POST prevention strategy in chronic mouth-breathers
- Preoperative mucosal hydration measured by Modified Schirmer Test and VAS dryness score before and after nebulization
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.
- Conditions
- Postoperative Sore Throat, Nasal Obstruction, Septoplasty
- Being tested
- Nebulized 0.9% Normal Saline, Water-Soluble Lubricant Gel on Endotracheal Tube, Sham Nebulization
- Keywords
- Postoperative sore throat, POST prevention, Nasal obstruction, NOSE score, Septoplasty, Pharyngeal mucosal conditioning, Nebulized saline, Endotracheal tube lubrication, Lubricant gel, Chronic mouth breathing, General anesthesia, Throat pack
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized 0.9% Normal SalineDevice
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 on Endotracheal TubeDevice
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.
Sham NebulizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Multimodal Pharyngeal Mucosal Conditioning | Experimental | 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. Receives: Device: Nebulized 0.9% Normal Saline; Device: Water-Soluble Lubricant Gel on Endotracheal Tube |
| Group B - Standard Care (Sham Control) | Sham comparator | 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. Receives: Device: Sham Nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after extubation
Secondary outcomes (8)
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.
Measured: 1 hour, 6 hours, and 24 hours post-extubation
Incidence and Severity of Hoarseness
1 hour, 6 hours, and 24 hours post-extubation
Measured: 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).
Measured: 1 hour and 6 hours post-extubation
Incidence of Postoperative Nausea and Vomiting
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 24 hours (pooled data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Tolba, Mansoura University
- Investigators
- Mohamed Ahmed Tolba, MD, Principal investigator, Mansoura University - Qassim University Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870252
- Sponsor's protocol ID
- QU-IRB-26-40-09-2026
- Other IDs
- 26-40-09
- Acronym
- POST-MUCOSAL R
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No