Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction (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
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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mohamed Ahmed Tolba, MD
- Telefonnummer: 00966507439018
- E-Mail: m_atolba1234@mans.edu.eg
Studieren Sie die Kontaktsicherung
- Name: Omar Saleh Al Misnid, MD
- Telefonnummer: 00966561205555
- E-Mail: O.almisnid@qu.edu.sa
Studienorte
-
-
Al-Qassim Region
-
Buraidah, Al-Qassim Region, Saudi-Arabien, 51452
- Rekrutierung
- Qassim University Medical City
-
Kontakt:
- Mohammed Ahmed Ahmed Tolba, MD
- Telefonnummer: 00966507439018
- E-Mail: m_atolba1234@mans.edu.eg
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Group A - Multimodal Pharyngeal Mucosal Conditioning
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. |
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. |
|
Schein-Komparator: Group B - Standard Care (Sham Control)
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. |
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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Postoperative Sore Throat (POST) at 1 Hour Post-Extubation
Zeitfenster: 1 hour after 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
POST Severity - Visual Analogue Scale
Zeitfenster: 1 hour, 6 hours, and 24 hours post-extubation
|
POST severity scored on VAS 0-10 (0=no pain, 10=worst imaginable pain) by blinded assessor at 1h, 6h, and 24h. |
1 hour, 6 hours, and 24 hours post-extubation
|
|
Incidence and Severity of Hoarseness
Zeitfenster: Hoarseness graded 0-3 (0=none; 1=mild/perceived only; 2=moderate/noticed by others; 3=severe/aphonia).
|
1 hour, 6 hours, and 24 hours post-extubation |
Hoarseness graded 0-3 (0=none; 1=mild/perceived only; 2=moderate/noticed by others; 3=severe/aphonia).
|
|
Incidence and Severity of Dysphagia
Zeitfenster: 1 hour and 6 hours post-extubation
|
Dysphagia graded 0-3 (0=none; 1=mild; 2=moderate/significant difficulty; 3=severe/unable to swallow). |
1 hour and 6 hours post-extubation
|
|
Incidence of Postoperative Nausea and Vomiting
Zeitfenster: 6 hours and 24 hours post-extubation
|
6 hours and 24 hours post-extubation
|
|
|
Time to First Analgesic Request for Throat Pain
Zeitfenster: From extubation to 24 hours post-extubation
|
Time in minutes from extubation to first patient-initiated request for analgesia specifically for throat pain. |
From extubation to 24 hours post-extubation
|
|
Preoperative Pharyngeal Mucosal Hydration
Zeitfenster: Before and after nebulization/sham, approximately 30-40 minutes pre-induction
|
Mucosal hydration measured by patient VAS dryness score (0-10). Measured before and after nebulization to confirm intervention effect. |
Before and after nebulization/sham, approximately 30-40 minutes pre-induction
|
|
Patient Satisfaction with Recovery
Zeitfenster: 24 hours post-extubation
|
Numerical Rating Scale 0-10 (0=completely unsatisfied, 10=completely satisfied). |
24 hours post-extubation
|
|
Dose-Response Correlation - NOSE Score and POST Severity
Zeitfenster: 24 hours (pooled data)
|
Exploratory Pearson/Spearman correlation between preoperative NOSE score (continuous variable) and POST VAS across both groups |
24 hours (pooled data)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mohamed Ahmed Tolba, MD, Mansoura University - Qassim University Medical City
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QU-IRB-26-40-09-2026
- 26-40-09 (Andere Kennung: Qassim University Bioethics IRB)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .