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NCT06818981
Post-Operative Steroids After Sleep Surgery
Conditions: Obstructive Sleep Apnea
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Sponsor: Medical University of South Carolina
Location: Medical University of South Carolina Charleston South Carolina
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Adults 18 years or older
* Undergoing sleep surgery, specifically palatopharyngoplasty, tonsillectomy with or without adenoidectomy, uvulectomy, hypoglossal nerve stimulation, genioglossal advancement, or maxillomandibular advancement
* Ability to complete all study questions in English
Exclusion Criteria:
* Any self-reported allergies to corticosteroids
* Intra-operative surgical or anesthetic complication
* Pre-operative steroid use (defined as any steroid use greater than three days duration within 30 days prior to sleep surgery)
* Inability to perform study due to underlying medical condition
* Inability to answer postoperative questionnaires due to underlying medical conditions
Source: ClinicalTrials.gov (NCT06818981). StuddyBuddy aggregates publicly available trial information.