Study Results
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View full resultsBasic Information
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COMPLETED
NA
84 participants
INTERVENTIONAL
2016-11-30
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Guanfacine
Guanfacine 1 mg capsule by mouth, one time prior to surgery.
Guanfacine
Patients will receive 1 mg of guanfacine to take orally.
Placebo
Placebo with a similar appearance to guanfacine by mouth one time prior to surgery
Placebo
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
Interventions
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Guanfacine
Patients will receive 1 mg of guanfacine to take orally.
Placebo
Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who take alpha-2 agonists routinely (guanfacine, clonidine, tizanidine)
* Patients undergoing sinus surgery planned for greater than 3 hours
* Patients with significant pre-existing pain, on chronic pain (opioid, methadone) therapy, severe fibromyalgia or other pre-existing pain condition in any body part
* Patients with preoperative nausea/vomiting at baseline.
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Stephen Harvey
Assistant Professor
Principal Investigators
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Stephen T Harvey, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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.
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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.
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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.
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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.
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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.
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.
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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.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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160282
Identifier Type: -
Identifier Source: org_study_id
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