drugset / Trial / NCT02882854
Guanfacine for PONV and Pain After Sinus Surgery
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Postoperative nausea and vomiting (PONV) and pain are the most common causes of Post Anesthesia Care Unit (PACU) discharge delay, with untreated PONV occurring in 20-30% of post-surgical patients. The effect of guanfacine (GF) administration on pain and nausea scores will be assessed with two groups. One group will receive 1 mg of GF to take orally and the other group will receive a similar appearing placebo (containing no drug) to take orally.
Timeline
- Start
- 2016-11
- Primary completion
- 2017-02
- Completion
- 2017-02
Publications
- Background Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
- Background Luttinger D, Ferrari R, Perrone MH, Haubrich DR. Pharmacological analysis of alpha-2 adrenergic mechanisms in nociception and ataxia. J Pharmacol Exp Ther. 1985 Mar;232(3):883-9.
- Background Yamadera H, Ferber G, Matejcek M, Pokorny R. Electroencephalographic and psychometric assessment of the CNS effects of single doses of guanfacine hydrochloride (Estulic) and clonidine (Catapres). Neuropsychobiology. 1985;14(2):97-107. doi: 10.1159/000118212.
- Background Connor DF, Arnsten AF, Pearson GS, Greco GF. Guanfacine extended release for the treatment of attention-deficit/hyperactivity disorder in children and adolescents. Expert Opin Pharmacother. 2014 Aug;15(11):1601-10. doi: 10.1517/14656566.2014.930437. Epub 2014 Jul 3.
- Background Massad IM, Mohsen WA, Basha AS, Al-Zaben KR, Al-Mustafa MM, Alghanem SM. A balanced anesthesia with dexmedetomidine decreases postoperative nausea and vomiting after laparoscopic surgery. Saudi Med J. 2009 Dec;30(12):1537-41.
- Background Kamibayashi T, Hayashi Y, Mammoto T, Yamatodani A, Sumikawa K, Yoshiya I. Role of the vagus nerve in the antidysrhythmic effect of dexmedetomidine on halothane/epinephrine dysrhythmias in dogs. Anesthesiology. 1995 Nov;83(5):992-9. doi: 10.1097/00000542-199511000-00013.
- Background Unnerstall JR, Kopajtic TA, Kuhar MJ. Distribution of alpha 2 agonist binding sites in the rat and human central nervous system: analysis of some functional, anatomic correlates of the pharmacologic effects of clonidine and related adrenergic agents. Brain Res. 1984 Mar;319(1):69-101. doi: 10.1016/0165-0173(84)90030-4.
- Background Giovannoni MP, Ghelardini C, Vergelli C, Dal Piaz V. Alpha2-agonists as analgesic agents. Med Res Rev. 2009 Mar;29(2):339-68. doi: 10.1002/med.20134.
- Background Aghajanian GK, Wang YY. Common alpha 2- and opiate effector mechanisms in the locus coeruleus: intracellular studies in brain slices. Neuropharmacology. 1987 Jul;26(7B):793-9. doi: 10.1016/0028-3908(87)90054-2.
- Background Ittermann T, Volzke H, Baumeister SE, Appel K, Grabe HJ. Diagnosed thyroid disorders are associated with depression and anxiety. Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1417-25. doi: 10.1007/s00127-015-1043-0. Epub 2015 Mar 17.
- Background Baser E, Togrul C, Ozgu E, Esercan A, Caglar M, Gungor T. Effect of pre-procedural state-trait anxiety on pain perception and discomfort in women undergoing colposcopy for cervical cytological abnormalities. Asian Pac J Cancer Prev. 2013;14(7):4053-6. doi: 10.7314/apjcp.2013.14.7.4053.
- Background Benarroch EE. The locus ceruleus norepinephrine system: functional organization and potential clinical significance. Neurology. 2009 Nov 17;73(20):1699-704. doi: 10.1212/WNL.0b013e3181c2937c. No abstract available.
- Background Goldman-Rakic PS. Cellular basis of working memory. Neuron. 1995 Mar;14(3):477-85. doi: 10.1016/0896-6273(95)90304-6. No abstract available.
- Background Wang M, Gamo NJ, Yang Y, Jin LE, Wang XJ, Laubach M, Mazer JA, Lee D, Arnsten AF. Neuronal basis of age-related working memory decline. Nature. 2011 Jul 27;476(7359):210-3. doi: 10.1038/nature10243.
- Background Goldman-Rakic PS. Circuitry of the frontal association cortex and its relevance to dementia. Arch Gerontol Geriatr. 1987 Sep;6(3):299-309. doi: 10.1016/0167-4943(87)90029-x.
- Background Hunt RD, Arnsten AF, Asbell MD. An open trial of guanfacine in the treatment of attention-deficit hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1995 Jan;34(1):50-4. doi: 10.1097/00004583-199501000-00013.
- Background Arnsten AF, Jin LE. Guanfacine for the treatment of cognitive disorders: a century of discoveries at Yale. Yale J Biol Med. 2012 Mar;85(1):45-58. Epub 2012 Mar 29.
- Background Zhao X, Tong D, Long B, Wu X. [Effects of different doses of dexmedetomidine on the recovery quality from general anesthesia undergoing thyroidectomy]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2014 Apr;26(4):239-43. doi: 10.3760/cma.j.issn.2095-4352.2014.04.008. Chinese.
- Background Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.
- Background Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.
- Background Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.
- Background Ozkose Z, Demir FS, Pampal K, Yardim S. Hemodynamic and anesthetic advantages of dexmedetomidine, an alpha 2-agonist, for surgery in prone position. Tohoku J Exp Med. 2006 Oct;210(2):153-60. doi: 10.1620/tjem.210.153.
- Background Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.
- Background Rago R, Forfori F, Materazzi G, Abramo A, Collareta M, Miccoli P, Giunta F. Evaluation of a preoperative pain score in response to pressure as a marker of postoperative pain and drugs consumption in surgical thyroidectomy. Clin J Pain. 2012 Jun;28(5):382-6. doi: 10.1097/AJP.0b013e3182326495.
- Background Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
- Background Charlson ME, Charlson RE, Peterson JC, Marinopoulos SS, Briggs WM, Hollenberg JP. The Charlson comorbidity index is adapted to predict costs of chronic disease in primary care patients. J Clin Epidemiol. 2008 Dec;61(12):1234-1240. doi: 10.1016/j.jclinepi.2008.01.006. Epub 2008 Jul 10.
- Background Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Background Aubrun F, Langeron O, Quesnel C, Coriat P, Riou B. Relationships between measurement of pain using visual analog score and morphine requirements during postoperative intravenous morphine titration. Anesthesiology. 2003 Jun;98(6):1415-21. doi: 10.1097/00000542-200306000-00017.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guanfacine | Small molecule | 1 mg | Oral |
Indications
No indication recorded.