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CompletedNCT07486544Throat packUpdated May 7, 2026

Soaked Pharyngeal Packing Agents in Septoplasty

A Phase 3 interventional study of Saline (NaCl 0,9 %) (placebo) and dexamethasone 8mg in Sore Throat, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Primary conditionPharyngitis(the registry's first term)UnverifiedIs this wrong?The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Assiut University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Sore Throat

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Keywords

  • Pharyngitis
  • Pharynx
  • Nasal Surgical Procedures
  • Dexamethasone
03

In context

Pharyngitis Unverified

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 65 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Preoperative sore throat,
  • Recent upper respiratory infections,
  • Anticipated difficult airway,
  • Existing digestive, respiratory, or cervical conditions,
  • Regular smoking,
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    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)

  • Active comparator
    Dexamethasone

    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

  • OtherSaline (NaCl 0,9 %) (placebo)

    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.

  • 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.

06

What researchers measure

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).

    Time frame: 1 hour

Secondary 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 and severity of Postoperative Sore Throat (POST) at 3, 6, 12, and 24 hours post surgery

    Time frame: 24 hours

  2. 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).

    Postoperative nausea and vomiting scores documented up to 6 hours (PACU admission, 3, and 6 hours)

    Time frame: 6 hours

  3. 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).

    Postoperative pain intensity evaluated using the Visual Analogue Scale (VAS) at various intervals (PACU admission, 3, 12, and 24 hours) up to 24 hours

    Time frame: 24 hours

07

Study locations

1 site
  • Assiut University
    Asyut, 71511, Egypt
08

References and documents

Publications

  • 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. PubMed 38074131 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2026 to primary completion in Apr 2026, 1 month.

Of 13 phase 3 interventional studies under Pharyngitis, half reached primary completion within 3 months of starting (the median); a quarter within 2 and three quarters within 6. This study's 1 month is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Mar 20, 2026
StartActual
Mar 20, 2026
Primary completionActual
Apr 25, 2026
CompletionActual
Apr 27, 2026
Last update
May 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07486544
Lead sponsor
Assiut University
Responsible party
Omar Makram Soliman (Associate Professor, Assiut University) — Principal investigator
First posted
Mar 20, 2026
Start date
Mar 20, 2026
Primary completion
Apr 25, 2026
Completion
Apr 27, 2026
Last update
May 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dexamethasone

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