Post-Operative Steroids After Sleep Surgery

Medical University of South Carolina (MUSC)

Status and phase: Active, not recruiting; Phase 2

Conditions: Obstructive Sleep Apnea

Treatments: Drug: 8mg dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06818981

Pro00138969

Details and patient eligibility

About

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.

Full description

Obstructive sleep apnea (OSA) is a multifactorial disease that negatively affects almost every system in the body. While continuous positive airway pressure (CPAP) can be used as an effective treatment, there are many reasons that patients cannot tolerate CPAP, including claustrophobia, rhinitis sicca, ineffectiveness, and manufacturer recalls that most recently have even been fatal. Therefore, sleep surgery continues to be an increasingly utilized treatment option for patients with OSA who cannot tolerate or obtain CPAP. However postoperatively, patients typically complain of significant pain, sometimes requiring a significant course of narcotic pain medication, odynophagia, and dysphagia. These side effects often can make patients hesitant to pursue sleep surgery and carry the risk of patients becoming dehydrated and malnourished postoperatively, which can lead to representation to the Emergency Department. Minimal research currently exists on how to improve treating pain, odynophagia, and dysphagia in this patient population. 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, in their study, they mention that likely their intervention was too short, and that further investigation into a longer course of steroid treatment, our current intervention for this study, could potentially show clinically significant improvements. Furthermore, there have been a few randomized controlled trials showing that a course of steroids improve pain and narcotic consumption after tonsillectomy in adults. However, no research has studies the postoperative effects of steroids on other sleep surgeries, such as palatopharyngoplasty, hypoglossal nerve stimulation, genioglossus advancement, or maxillomandibular advancement. Investigators hypothesize that postoperative steroids will be superior to no steroids in terms of pain, dysphagia, and narcotic usage.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

3 doses of intravenous 8mg dexamethasone with 3 doses of oral 8mg dexamethasone

Experimental group

Description:

Experimental drug administered both intravenously and orally

Treatment:

Drug: 8mg dexamethasone

3 doses of intravenous 8mg dexamethasone with 3 doses of placebo

Other group

Description:

Experimental drug administered intravenously, while the placebo is administered orally

Treatment:

Drug: 8mg dexamethasone

3 doses of intravenous placebo with 3 doses of oral 8mg dexamethasone

Other group

Description:

Placebo administered intravenously, while the experimental drug is administered orally

Treatment:

Drug: 8mg dexamethasone

3 doses of intravenous placebo with 3 doses of placebo

Placebo Comparator group

Description:

Placebo administered both intravenously and orally

Treatment:

Drug: 8mg dexamethasone