Post-Operative Steroids After Sleep Surgery

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06818981
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 8mg dexamethasone — DRUG
    Minimal research exists on how to treat pain, odynophagia, and dysphagia in sleep surgery patients. One study by Williams et al. evaluated the use of a one-time dose of intravenous or intramuscular dose of steroids versus placebo after uvulopalatopharyngoplasty but did not find a clinically significant difference between the two groups postoperatively. However this study mentioned that their current intervention was too short and that a longer-term steroid intervention could be beneficial. This is the goal of this intervention.

Study Details

The primary objective of this randomized, placebo-controlled, double-blind study will be to determine if postoperative steroids significantly improve subjects' pain compared to a placebo after undergoing sleep surgery. The secondary objective is to determine if this same course of steroids improves how quickly subjects can tolerate a regular diet after surgery. Further, another secondary objective is to see if this will decrease a patient's postoperative narcotic usage. Investigators also will assess sleepiness, nasal breathing, and eustachian tube dysfunction (ETD) after the procedure using the validated measures Preoperative Epworth Sleepiness Scale (ESS), Nasal Obstruction Symptom Evaluation Survey (NOSE), and Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with an objective to see if these improve more or quicker in patients who receive postoperative steroids. Investigators hypothesize that postoperative steroids will significantly decrease a patient's pain quicker in their recovery, allow them to tolerate more oral intake early in their recovery, allow them to tolerate a regular diet earlier in their recovery, and reduce their postoperative narcotic usage. Investigators hypothesize that postoperative steroids will also improve patients' ESS, NOSE, and ETD scores postoperatively, but Investigators do not believe postoperative steroids will affect the oropharyngeal bleeding rate of patients. This study will provide pilot data to determine if postoperative steroids and what dosage should be part of a standardized postoperative regimen in patients undergoing sleep surgery.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 3 doses of intravenous 8mg dexamethasone with 3 doses of oral 8mg dexamethasone
    Experimental drug administered both intravenously and orally
  • Other: 3 doses of intravenous 8mg dexamethasone with 3 doses of placebo
    Experimental drug administered intravenously, while the placebo is administered orally
  • Other: 3 doses of intravenous placebo with 3 doses of oral 8mg dexamethasone
    Placebo administered intravenously, while the experimental drug is administered orally
  • Placebo Comparator: 3 doses of intravenous placebo with 3 doses of placebo
    Placebo administered both intravenously and orally

Primary Outcome Measure

Pain control [ Time Frame: 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29412-

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By research site
Medical University of South Carolina· Charleston, SC

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