Loading clinical trials...
Loading clinical trials...
Comparative Evaluation of Soaked Pharyngeal Packing Agents in Septoplasty Procedure: Impact on Postoperative Outcomes
Postoperative sore throat (POST) is a frequent and distressing complication after general anesthesia with endotracheal intubation, particularly in nasal surgery for example, functional endoscopic sinus surgery, septoplasty, or septo-rhinoplasty, where pharyngeal packing is routine. While pharyngeal packs may reduce blood ingestion, they may exacerbate POST, warranting effective pharmacologic prophylaxis. This study assesses the efficacy of dexamethasone-soaked pharyngeal packs in reducing incidence of POST in patients undergoing elective septoplasty surgeries.
Allocation will be concealed in opaque, sealed envelopes, opened only after patient recruitment. A nurse who will be blinded to the group assignment prepared the pharyngeal packs. A sterile, non-absorbable gauze strip that will be between 30 and 50 cm² in size and with a retrieval thread for atraumatic removal made up each intervention pack. for 30 seconds, the gauze will be submerged in either 25 ml of saline solution containing dexamethasone (8 mg) or 25 ml of 0.9% saline for the control group. These dosages will be given in accordance with published data showing the safety and effectiveness of these concentrations in earlier research employing comparable quantities for anti-inflammatory and analgesic effects. Study protocol: Intraoperatively, standard monitoring, as advised by the ASA, will be implemented. Induction will be conducted with lidocaine (1 mg/kg), propofol (3 mg/kg), fentanyl (1 μg/kg), and rocuronium (0.8 mg/kg). Endotracheal tubes (6.5 mm for females, 7 mm for males) will be coated with 2% lidocaine jelly prior to intubation. Cuff pressures will be sustained at 20-22 cmH2O for the whole surgical procedure utilizing a manometer. The anesthetist, unaware of group allocation, will place the pharyngeal pack under direct visualization following intubation. The pharyngeal pack is situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement is executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients. Anesthesia maintenance employe sevoflurane combined with an oxygen-air combination, while intravenous fluids will be administered at a rate of 2 mL/kg/hr. Pre-extubation analgesia include 1 g of paracetamol. All intubations will be executed by experienced anesthetists, potentially reducing traumatic intubation and many attempts, which are acknowledged factors contributing to postoperative sore throat. The duration of the procedure and any oropharyngeal hemorrhaging, characterized as observable bleeding from the oropharynx during the emergence from anesthesia, will be recorded. All patients will be administered absorbable nasal packing immediately following the surgical procedure to manage hemorrhage, applied consistently across all groups. No topical anesthetics or vasoconstrictors will be administered. All patients receive standard intravenous dexamethasone (8 mg) intraoperatively in accordance with our institutional practice to avoid postoperative nausea and vomiting (PONV). Post-surgery, oropharyngeal suctioning will be conducted under direct visualization, and the pharyngeal pack is extracted once the patient regained complete consciousness, achieved hemodynamic stability, and satisfied extubation requirements. Patients are then sent to the Post-Anesthesia Care Unit (PACU). An anesthetist, unaware of group assignment, document intraoperative and postoperative data. The primary outcome is the incidence of postoperative sore throat (POST) at 1-hour post-surgery; assessment is done at PACU every 30 min for 1 h (0, 30, 60 min). Secondary outcomes encompass the incidence and severity of POST at 3, 6, 12, and 24 hours; postoperative nausea and vomiting (PONV) scores will be documented up to 6 hours (PACU admission, 3, and 6 hours); postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) at various intervals (PACU admission, 3, 12, and 24 hours) up to 24 hours; and total postoperative pethidine consumption. POST severity is classified as a standardized 4-point scale as 0 when there is no sore throat, 1 for mild sore throat, 2 when discomfort is moderate, and 3 for severe sore throat associated with hoarseness. PONV is assessed and documented by the PACU nurses using a verbal descriptive score aligned with a visual analogue nausea scale, facilitating an objective assessment of severity. A score of 0 indicated the absence of nausea and vomiting post-surgery, 1 denoted mild postoperative nausea without vomiting or the necessity for antiemetics, 2 signified moderate nausea post-surgery necessitating antiemetic intervention, and 3 represented postoperative nausea accompanied by vomiting, and 8 mg IV ondansetron will be given at grade 2. Pain intensity is assessed using a 10 cm Visual Analog Scale (VAS), where 0 indicated no pain and 10 the worst imaginable pain. Pain severity is categorized as mild (0-3), moderate (4-6), or severe (7-10). Pethidine 0.5 mg/kg is administered for scores ≥4. All assessments will be conducted by observers blinded to the groups.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Assiut University
Asyut, Egypt
Start Date
March 20, 2026
Primary Completion Date
June 1, 2026
Completion Date
June 4, 2026
Last Updated
March 20, 2026
90
ESTIMATED participants
Saline (NaCl 0,9 %) (placebo)
OTHER
dexamethasone 8mg
DRUG
Lead Sponsor
Assiut University
NCT06967896
NCT07341646
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions