Esteroides postoperatorios después de la cirugía de sueño
Un ensayo clínico aleatorizado, doble ciego, controlado con placebo de esteroides postoperatorios después de una cirugía de sueño
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29412
- Medical University of South Carolina
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Otro: 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.
Otros nombres:
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Otro: 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.
Otros nombres:
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Comparador de placebos: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain control
Periodo de tiempo: 2 weeks
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicolas Poupore, Medical University of South Carolina
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Apnea
- Trastornos del Sueño Intrínsecos
- Disomnias
- Síndromes de apnea del sueño
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor
- Apnea del Sueño Obstructiva
- Trastornos del sueño y la vigilia
- Compuestos de azufre
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Derivados de benceno
- Ácidos sulfónicos
- Ácidos de azufre
- Esparrazadienetrioles
- Bencenosulfonatos
- Arilsulfonatos
- Ácidos arilsulfónicos
- Dexametasona
- Dobesilato de calcio
Otros números de identificación del estudio
- Pro00138969
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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