睡眠手术后术后类固醇
睡眠手术后术后类固醇的随机，双盲，安慰剂对照的临床试验
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.
研究概览
详细说明
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.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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South Carolina
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Charleston、South Carolina、美国、29412
- Medical University of South Carolina
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：3 doses of intravenous 8mg dexamethasone with 3 doses of oral 8mg dexamethasone
Experimental drug administered both intravenously and orally |
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.
其他名称：
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其他：3 doses of intravenous 8mg dexamethasone with 3 doses of placebo
Experimental drug administered intravenously, while the placebo is administered orally |
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.
其他名称：
|
|
其他：3 doses of intravenous placebo with 3 doses of oral 8mg dexamethasone
Placebo administered intravenously, while the experimental drug is administered orally |
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.
其他名称：
|
|
安慰剂比较：3 doses of intravenous placebo with 3 doses of placebo
Placebo administered both intravenously and orally |
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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain control
大体时间：2 weeks
|
As determined by a validated visual analog scale, with scores being scaled from 0 to 10, with 0 being the lowest score (no pain) and 10 being the highest score (most extreme amount of pain) |
2 weeks
|
合作者和调查者
调查人员
- 首席研究员：Nicolas Poupore、Medical University of South Carolina
出版物和有用的链接
一般刊物
- Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
- Stewart R, Bill R, Ullah R, McConaghy P, Hall SJ. Dexamethasone reduces pain after tonsillectomy in adults. Clin Otolaryngol Allied Sci. 2002 Oct;27(5):321-6. doi: 10.1046/j.1365-2273.2002.00588.x.
- Lachance M, Lacroix Y, Audet N, Savard P, Thuot F. The use of dexamethasone to reduce pain after tonsillectomy in adults: a double-blind prospective randomized trial. Laryngoscope. 2008 Feb;118(2):232-6. doi: 10.1097/MLG.0b013e318159a5cc.
- Williams PM, Strome M, Eliachar I, Lavertu P, Wood BG, Vito KJ. Impact of steroids on recovery after uvulopalatopharyngoplasty. Laryngoscope. 1999 Dec;109(12):1941-6. doi: 10.1097/00005537-199912000-00008.
- Abdelwahab M, Marques S, Howard J, Huang A, Lechner M, Olds C, Capasso R. Incidence and risk factors of chronic opioid use after sleep apnea surgery. J Clin Sleep Med. 2022 Jul 1;18(7):1805-1813. doi: 10.5664/jcsm.9978.
- Shah RR, Thaler ER. Base of Tongue Surgery for Obstructive Sleep Apnea in the Era of Neurostimulation. Otolaryngol Clin North Am. 2020 Jun;53(3):431-443. doi: 10.1016/j.otc.2020.02.006. Epub 2020 Apr 23.
- Barrera JE. Skeletal Surgery for Obstructive Sleep Apnea. Sleep Med Clin. 2018 Dec;13(4):549-558. doi: 10.1016/j.jsmc.2018.07.006.
- Smith DF, Cohen AP, Ishman SL. Surgical management of OSA in adults. Chest. 2015 Jun;147(6):1681-1690. doi: 10.1378/chest.14-2078.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro00138969
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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