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Post-Operative Steroids After Sleep Surgery

StatusWithdrawn
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Stopped Withdrawn before enrolling Sponsor's reason: Lack of funding Enrollment target: estimated 120 to confirmed 0 · Primary completion date changed from estimate of Jun 30, 2027 to Jul 1, 2026 · Eligibility criteria expanded, about 8 words · 1 more Show 4 more changesShow less
    • Enrollment target: estimated 120 to confirmed 0
    • Primary completion date changed from estimate of Jun 30, 2027 to Jul 1, 2026
    • Eligibility criteria expanded, about 8 words
    • Publications: details revised at 8 of 8 entries
  2. Notable Start date: Feb 1, 2025 to Jul 1, 2026 Trial status: Active, Not Recruiting to Not Yet Recruitingv3 Show 1 more changeShow less
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06818981
Lead Sponsor Medical University of South Carolina
Conditions Obstructive Sleep Apnea
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov