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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mohamed Ahmed Tolba, MD
- Número de telefone: 00966507439018
- E-mail: m_atolba1234@mans.edu.eg
Estude backup de contato
- Nome: Omar Saleh Al Misnid, MD
- Número de telefone: 00966561205555
- E-mail: O.almisnid@qu.edu.sa
Locais de estudo
-
-
Al-Qassim Region
-
Buraidah, Al-Qassim Region, Arábia Saudita, 51452
- Recrutamento
- Qassim University Medical City
-
Contato:
- Mohammed Ahmed Ahmed Tolba, MD
- Número de telefone: 00966507439018
- E-mail: m_atolba1234@mans.edu.eg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Comparador Falso: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Postoperative Sore Throat (POST) at 1 Hour Post-Extubation
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
POST Severity - Visual Analogue Scale
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 hours and 24 hours post-extubation
|
6 hours and 24 hours post-extubation
|
|
|
Time to First Analgesic Request for Throat Pain
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 hours (pooled data)
|
Exploratory Pearson/Spearman correlation between preoperative NOSE score (continuous variable) and POST VAS across both groups |
24 hours (pooled data)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed Ahmed Tolba, MD, Mansoura University - Qassim University Medical City
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- QU-IRB-26-40-09-2026
- 26-40-09 (Outro identificador: Qassim University Bioethics IRB)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .