[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659847":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":57,"studyPopulation":27,"armGroups":58,"interventions":72,"overallOfficials":86,"centralContacts":91,"locations":100,"responsibleParty":117,"collaborators":27,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":27,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":154,"whyStopped":27,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Mansoura University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,25,29,33,37,41],{"measure":15,"description":16,"timeFrame":17},"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.","1 hour, 6 hours, and 24 hours post-extubation",{"measure":19,"description":17,"timeFrame":20},"Incidence and Severity of Hoarseness","Hoarseness graded 0-3 (0=none; 1=mild\u002Fperceived only; 2=moderate\u002Fnoticed by others; 3=severe\u002Faphonia).",{"measure":22,"description":23,"timeFrame":24},"Incidence and Severity of Dysphagia","Dysphagia graded 0-3 (0=none; 1=mild; 2=moderate\u002Fsignificant difficulty; 3=severe\u002Funable to swallow).","1 hour and 6 hours post-extubation",{"measure":26,"description":27,"timeFrame":28},"Incidence of Postoperative Nausea and Vomiting",null,"6 hours and 24 hours post-extubation",{"measure":30,"description":31,"timeFrame":32},"Time to First Analgesic Request for Throat Pain","Time in minutes from extubation to first patient-initiated request for analgesia specifically for throat pain.","From extubation to 24 hours post-extubation",{"measure":34,"description":35,"timeFrame":36},"Preoperative Pharyngeal Mucosal Hydration","Mucosal hydration measured by patient VAS dryness score (0-10). Measured before and after nebulization to confirm intervention effect.","Before and after nebulization\u002Fsham, approximately 30-40 minutes pre-induction",{"measure":38,"description":39,"timeFrame":40},"Patient Satisfaction with Recovery","Numerical Rating Scale 0-10 (0=completely unsatisfied, 10=completely satisfied).","24 hours post-extubation",{"measure":42,"description":43,"timeFrame":44},"Dose-Response Correlation - NOSE Score and POST Severity","Exploratory Pearson\u002FSpearman correlation between preoperative NOSE score (continuous variable) and POST VAS across both groups","24 hours (pooled data)",{"allocation":46,"interventionModel":47,"interventionModelDescription":27,"primaryPurpose":48,"observationalModel":27,"timePerspective":27,"maskingInfo":49},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":50,"maskingDescription":51,"whoMasked":52},"QUADRUPLE","Sham nebulizer delivers room air through an identical device producing the same sound and airflow as the active device. The lubricant gel is applied to the ETT by the anesthesiologist after surgical draping and is not visible to the patient, surgeon, or outcomes assessor. The PACU nurse assessing all postoperative endpoints is blinded to group allocation and was not present during induction.",[53,54,55,56],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","BACKGROUND:\n\nExisting 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.\n\nINTERVENTION:\n\nGroup 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.\n\nGroup B (Control): Sham nebulization (room air, identical device and duration); ETT lubricated with plain water only.\n\nSTANDARDIZED PROTOCOL (both groups):\n\nInduction: propofol 1.5-2 mg\u002Fkg + fentanyl 1-2 µg\u002Fkg + rocuronium 0.6 mg\u002Fkg. Maintenance: sevoflurane 1.0-1.5 MAC in O2\u002FAir (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.\n\nNOVEL ELEMENTS:\n\n1. First RCT to enroll nasal surgery patients specifically by NOSE score severity\n2. First study to test preoperative mucosal conditioning as a POST prevention strategy in chronic mouth-breathers\n3. Preoperative mucosal hydration measured by Modified Schirmer Test and VAS dryness score before and after nebulization\n\nRANDOMIZATION AND BLINDING:\n\nComputer-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.\n\nSAMPLE SIZE:\n\nn=105 (52-53\u002Fgroup); 80% power; two-sided alpha=0.05; anticipated 65% POST incidence in control group; clinically meaningful absolute reduction of 35%; 15% dropout allowance.",[59,66],{"label":60,"type":61,"description":62,"interventionNames":63},"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.",[64,65],"Device: Nebulized 0.9% Normal Saline","Device: Water-Soluble Lubricant Gel on Endotracheal Tube",{"label":67,"type":68,"description":69,"interventionNames":70},"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.",[71],"Device: Sham Nebulization",[73,78,82],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":27},"DEVICE","Nebulized 0.9% Normal Saline","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.",[60],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":27},"Water-Soluble Lubricant Gel on Endotracheal Tube","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.",[60],{"type":74,"name":83,"description":84,"armGroupLabels":85,"otherNames":27},"Sham Nebulization","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.",[67],[87],{"name":88,"affiliation":89,"role":90},"Mohamed Ahmed Tolba, MD","Mansoura University - Qassim University Medical City","PRINCIPAL_INVESTIGATOR",[92,96],{"name":88,"role":93,"phone":94,"phoneExt":27,"email":95},"CONTACT","00966507439018","m_atolba1234@mans.edu.eg",{"name":97,"role":93,"phone":98,"phoneExt":27,"email":99},"Omar Saleh Al Misnid, MD","00966561205555","O.almisnid@qu.edu.sa",[101],{"facility":102,"status":27,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Qassim University Medical City","Buraidah","Al-Qassim Region","51452","Saudi Arabia","SA",{"type":109,"coordinates":110},"Point",[111,112],43.97497,26.32599,{"lat":112,"lon":111},[115],{"name":116,"role":93,"phone":94,"phoneExt":27,"email":95},"Mohammed Ahmed Ahmed Tolba, MD",{"type":90,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Mohamed Ahmed Tolba","Assistant Professor","100659847","pharyngeal-mucosal-conditioning-to-prevent-postoperative-sore-throat-in-septoplasty-patients-with-severe-nasal-obstruction-a-double-blind-rct-100659847",false,"NCT07870252","Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction: A Double-Blind RCT","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","POST-MUCOSAL R","Inclusion Criteria:\n\n* Age 18 to 60 years\n* ASA physical status I or II\n* NOSE score ≥55 (severe or extreme nasal obstruction category) at preoperative assessment\n* Duration of nasal obstruction symptoms ≥6 months\n* Scheduled for elective septoplasty ± turbinoplasty under general anesthesia with endotracheal intubation\n* Mallampati class I or II\n* BMI ≤35 kg\u002Fm²\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Current or past smoker (any amount)\n* Gastroesophageal reflux disease (GERD) or laryngopharyngeal reflux (LPR)\n* Known pharyngeal or laryngeal pathology\n* Active upper respiratory tract infection within 2 weeks of scheduled surgery\n* Preoperative sore throat or baseline pharyngeal pain at time of assessment\n* Anticipated difficult airway (Mallampati class III-IV, mouth opening less than 3 cm)\n* ACE inhibitor use (causes dry cough, confounds POST assessment)\n* Concurrent tonsillectomy, adenoidectomy, or rhinoplasty extending operative time beyond 90 minutes\n* Known allergy to lubricant gel components\n* Severe systemic disease affecting mucosal hydration (Sjögren's syndrome, uncontrolled diabetes mellitus, end-stage renal disease)\n* Pregnancy or breastfeeding\n* Previous participation in this study","ALL","18 Years","60 Years",{"count":132,"type":133},105,"ESTIMATED","INTERVENTIONAL",[136],"NA","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.\n\nThis 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).\n\n105 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.",[139,140,141],"Postoperative Sore Throat","Nasal Obstruction","Septoplasty",[143,144,145,146,141,147,148,149,150,151,152,153],"Postoperative sore throat","POST prevention","Nasal obstruction","NOSE score","Pharyngeal mucosal conditioning","Nebulized saline","Endotracheal tube lubrication","Lubricant gel","Chronic mouth breathing","General anesthesia","Throat pack","NOT_YET_RECRUITING","2026-10-06",{"date":157,"type":158},"2026-10-13","ACTUAL",{"date":160,"type":133},"2026-10-15",{"date":162,"type":133},"2027-04-30",{"name":5,"class":6},1]