Soaked Pharyngeal Packing Agents in Septoplasty

NCT07486544 | Completed Phase 3

• 1 other identifier: 04-2026-300826
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sore Throat

Keywords

Pharyngitis; Pharynx; Nasal Surgical Procedures; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Postoperative sore throat (POST) score: 4-point scale as 0 for no sore throat (better outcome), and 3 for severe sore throat associated with hoarseness (worse outcome).

  The incidence of postoperative sore throat (POST) at 1-hour post-surgery and assessment will be done at Post Anesthesia Care Unit (PACU) every 30 minutes for 1 hour (at Post Anesthesia Care Unit (PACU) admission, 30, and 60 minutes).

  1 hour

Secondary Outcomes (3)

• Postoperative Sore Throat (POST) score: 4-point scale as 0 for no sore throat (better outcome) and 3 for severe sore throat associated with hoarseness (worse outcome).

  24 hours

• Postoperative nausea and vomiting (PONV) score: A 4-point scale with 0 for absence of nausea and vomiting (better outcome), and 3 for postoperative nausea accompanied by vomiting (worse outcome).

  6 hours

• Visual Analogue Scale (VAS) pain score: a 10 cm Visual Analog Scale, where 0 indicated no pain (better outcome), and 10 the worst imaginable pain (worse outcome).

  24 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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, then for 30 seconds, the gauze is submerged in 25 ml of normal saline solution

Other: Saline (NaCl 0,9 %) (placebo)

Dexamethasone

ACTIVE COMPARATOR

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, then for 30 seconds, the gauze is submerged in 8 mg dexamethasone and 25 ml of normal saline solution

Drug: dexamethasone 8mg

Interventions

Saline (NaCl 0,9 %) (placebo) OTHER

The anesthetist, unaware of group allocation, will place the saline soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.

Placebo

dexamethasone 8mg DRUG

The anesthetist, unaware of group allocation, will place the dexamethasone soaked pharyngeal pack under direct visualization following intubation. The pharyngeal pack will be situated in the oropharynx, positioned posterior to the soft palate and in contact with the posterior pharyngeal wall. Placement will be executed with forceps under direct observation, adhering to a standardized protocol to guarantee uniformity across all patients.

Dexamethasone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 65 years,
• Both male and female,
• Classified as American Society of Anesthesiologists (ASA) physical status I to III, and
• Scheduled for elective septoplasty.

You may not qualify if:

• Preoperative sore throat,
• Recent upper respiratory infections,
• Anticipated difficult airway,
• Existing digestive, respiratory, or cervical conditions,
• Regular smoking,
• Steroid use within 48 hours prior to surgery, and
• Pregnancy.
• Patients on chronic corticosteroid therapy, antitussives, or antihypertensive medications
• With known effects on airway reactivity or bleeding risk,
• Those with uncontrolled hypertension, or
• With known allergies to any of the study medications or their components

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (1)

• Mazzotta E, Soghomonyan S, Hu LQ. Postoperative sore throat: prophylaxis and treatment. Front Pharmacol. 2023 Nov 23;14:1284071. doi: 10.3389/fphar.2023.1284071. eCollection 2023.

  PMID: 38074131 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Pharyngitis

Interventions

Sodium Chloride; Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: March 20, 2026
• Primary Completion: April 25, 2026
• Study Completion: April 27, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

EG (1)