drugset / Trial / NCT03613558
Dex as Analgesic Adjuvant in OSA Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess whether intravenous peri-operative Dexmedetomidine reduces opioid requirements and or improves pain control after Uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea (OSA).
Timeline
- Start
- 2014-07
- Primary completion
- 2015-06
- Completion
- 2015-06
Publications
- Background Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Background Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. doi: 10.1016/j.smrv.2004.07.002.
- Background Kaw R, Pasupuleti V, Walker E, Ramaswamy A, Foldvary-Schafer N. Postoperative complications in patients with obstructive sleep apnea. Chest. 2012 Feb;141(2):436-441. doi: 10.1378/chest.11-0283. Epub 2011 Aug 25.
- Background Siyam MA, Benhamou D. Difficult endotracheal intubation in patients with sleep apnea syndrome. Anesth Analg. 2002 Oct;95(4):1098-102, table of contents. doi: 10.1097/00000539-200210000-00058.
- Background Reeder MK, Goldman MD, Loh L, Muir AD, Casey KR, Gitlin DA. Postoperative obstructive sleep apnoea. Haemodynamic effects of treatment with nasal CPAP. Anaesthesia. 1991 Oct;46(10):849-53. doi: 10.1111/j.1365-2044.1991.tb09599.x.
- Background Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.
- Background Farag E, Ghobrial M, Sessler DI, Dalton JE, Liu J, Lee JH, Zaky S, Benzel E, Bingaman W, Kurz A. Effect of perioperative intravenous lidocaine administration on pain, opioid consumption, and quality of life after complex spine surgery. Anesthesiology. 2013 Oct;119(4):932-40. doi: 10.1097/ALN.0b013e318297d4a5.
- Background Berger R, Hsu JC. Bioequivalence trials, intersection-union tests and equivalence confidence sets. Statis Sci. 1996;11:283-319
- Background American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed: Diagnostic and coding manual, American Academy of Sleep Medicine, Westchester, IL 2005.
- Background FDA. (2012, August 15) FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. FDA.gov Retrieved August 8, 2013 from http://www.fda.gov/Drugs/DrugSafety/ucm313631.htm#safety.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intravenous |