Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
NCT ID: NCT01344759
Last Updated: 2018-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2009-06-30
2011-11-30
Brief Summary
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The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Propofol
Propofol
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Dexmedetomidine
Dexmedetomidine
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
Interventions
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Dexmedetomidine
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
Propofol
Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must be 12 months to 25 years of age (inclusive)
3. Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study
Exclusion Criteria
2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
3. The subject has a tracheostomy or other mechanical airway device
4. The subject is not scheduled to receive anesthesia-sedation care for the MRI
5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
12 Months
25 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Mohamed Mahmoud, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents. doi: 10.1213/01.ane.0000216293.16613.15.
Ebert TJ, Hall JE, Barney JA, Uhrich TD, Colinco MD. The effects of increasing plasma concentrations of dexmedetomidine in humans. Anesthesiology. 2000 Aug;93(2):382-94. doi: 10.1097/00000542-200008000-00016.
Talke P, Lobo E, Brown R. Systemically administered alpha2-agonist-induced peripheral vasoconstriction in humans. Anesthesiology. 2003 Jul;99(1):65-70. doi: 10.1097/00000542-200307000-00014.
Talke P, Richardson CA, Scheinin M, Fisher DM. Postoperative pharmacokinetics and sympatholytic effects of dexmedetomidine. Anesth Analg. 1997 Nov;85(5):1136-42. doi: 10.1097/00000539-199711000-00033.
Doze VA, Chen BX, Maze M. Dexmedetomidine produces a hypnotic-anesthetic action in rats via activation of central alpha-2 adrenoceptors. Anesthesiology. 1989 Jul;71(1):75-9. doi: 10.1097/00000542-198907000-00014.
Drummond GB. Comparison of sedation with midazolam and ketamine: effects on airway muscle activity. Br J Anaesth. 1996 May;76(5):663-7. doi: 10.1093/bja/76.5.663.
Drummond GB. Influence of thiopentone on upper airway muscles. Br J Anaesth. 1989 Jul;63(1):12-21. doi: 10.1093/bja/63.1.12.
Hwang JC, St John WM, Bartlett D Jr. Respiratory-related hypoglossal nerve activity: influence of anesthetics. J Appl Physiol Respir Environ Exerc Physiol. 1983 Sep;55(3):785-92. doi: 10.1152/jappl.1983.55.3.785.
Hudgel DW, Harasick T, Katz RL, Witt WJ, Abelson TI. Uvulopalatopharyngoplasty in obstructive apnea. Value of preoperative localization of site of upper airway narrowing during sleep. Am Rev Respir Dis. 1991 May;143(5 Pt 1):942-6. doi: 10.1164/ajrccm/143.5_Pt_1.942.
Nandi PR, Charlesworth CH, Taylor SJ, Nunn JF, Dore CJ. Effect of general anaesthesia on the pharynx. Br J Anaesth. 1991 Feb;66(2):157-62. doi: 10.1093/bja/66.2.157.
SAFAR P, ESCARRAGA LA, CHANG F. Upper airway obstruction in the unconscious patient. J Appl Physiol. 1959 Sep;14:760-4. doi: 10.1152/jappl.1959.14.5.760. No abstract available.
Litman RS, Kottra JA, Berkowitz RJ, Ward DS. Upper airway obstruction during midazolam/nitrous oxide sedation in children with enlarged tonsils. Pediatr Dent. 1998 Sep-Oct;20(5):318-20.
Donnelly LF, Casper KA, Chen B, Koch BL. Defining normal upper airway motion in asymptomatic children during sleep by means of cine MR techniques. Radiology. 2002 Apr;223(1):176-80. doi: 10.1148/radiol.2231011023.
Donnelly LF, Shott SR, LaRose CR, Chini BA, Amin RS. Causes of persistent obstructive sleep apnea despite previous tonsillectomy and adenoidectomy in children with down syndrome as depicted on static and dynamic cine MRI. AJR Am J Roentgenol. 2004 Jul;183(1):175-81. doi: 10.2214/ajr.183.1.1830175.
Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.
Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.
Petroz GC, Sikich N, James M, van Dyk H, Shafer SL, Schily M, Lerman J. A phase I, two-center study of the pharmacokinetics and pharmacodynamics of dexmedetomidine in children. Anesthesiology. 2006 Dec;105(6):1098-110. doi: 10.1097/00000542-200612000-00009.
Mahmoud M, Tyler T, Sadhasivam S. Dexmedetomidine and ketamine for large anterior mediastinal mass biopsy. Paediatr Anaesth. 2008 Oct;18(10):1011-3. doi: 10.1111/j.1460-9592.2008.02604.x. No abstract available.
Eastwood PR, Platt PR, Shepherd K, Maddison K, Hillman DR. Collapsibility of the upper airway at different concentrations of propofol anesthesia. Anesthesiology. 2005 Sep;103(3):470-7. doi: 10.1097/00000542-200509000-00007.
Mason KP, Zurakowski D, Zgleszewski SE, Robson CD, Carrier M, Hickey PR, Dinardo JA. High dose dexmedetomidine as the sole sedative for pediatric MRI. Paediatr Anaesth. 2008 May;18(5):403-11. doi: 10.1111/j.1460-9592.2008.02468.x. Epub 2008 Mar 18.
Mason KP, Zgleszewski SE, Prescilla R, Fontaine PJ, Zurakowski D. Hemodynamic effects of dexmedetomidine sedation for CT imaging studies. Paediatr Anaesth. 2008 May;18(5):393-402. doi: 10.1111/j.1460-9592.2008.02451.x. Epub 2008 Mar 18.
Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. doi: 10.1213/01.ANE.0000219592.82598.AA.
Usher AG, Kearney RA, Tsui BC. Propofol total intravenous anesthesia for MRI in children. Paediatr Anaesth. 2005 Jan;15(1):23-8. doi: 10.1111/j.1460-9592.2004.01390.x.
Frankville DD, Spear RM, Dyck JB. The dose of propofol required to prevent children from moving during magnetic resonance imaging. Anesthesiology. 1993 Nov;79(5):953-8. doi: 10.1097/00000542-199311000-00013.
Levati A, Colombo N, Arosio EM, Savoia G, Tommasino C, Scialfa G, Boselli L. Propofol anaesthesia in spontaneously breathing paediatric patients during magnetic resonance imaging. Acta Anaesthesiol Scand. 1996 May;40(5):561-5. doi: 10.1111/j.1399-6576.1996.tb04488.x.
Evans RG, Crawford MW, Noseworthy MD, Yoo SJ. Effect of increasing depth of propofol anesthesia on upper airway configuration in children. Anesthesiology. 2003 Sep;99(3):596-602. doi: 10.1097/00000542-200309000-00014.
Litman RS, Weissend EE, Shrier DA, Ward DS. Morphologic changes in the upper airway of children during awakening from propofol administration. Anesthesiology. 2002 Mar;96(3):607-11. doi: 10.1097/00000542-200203000-00016.
Mathru M, Esch O, Lang J, Herbert ME, Chaljub G, Goodacre B, vanSonnenberg E. Magnetic resonance imaging of the upper airway. Effects of propofol anesthesia and nasal continuous positive airway pressure in humans. Anesthesiology. 1996 Feb;84(2):273-9. doi: 10.1097/00000542-199602000-00004.
Thompson JR, Schneider S, Ashwal S, Holden BS, Hinshaw DB Jr, Hasso AN. The choice of sedation for computed tomography in children: a prospective evaluation. Radiology. 1982 May;143(2):475-9. doi: 10.1148/radiology.143.2.7071350.
Napoli KL, Ingall CG, Martin GR. Safety and efficacy of chloral hydrate sedation in children undergoing echocardiography. J Pediatr. 1996 Aug;129(2):287-91. doi: 10.1016/s0022-3476(96)70256-1.
Greenberg SB, Faerber EN, Aspinall CL, Adams RC. High-dose chloral hydrate sedation for children undergoing MR imaging: safety and efficacy in relation to age. AJR Am J Roentgenol. 1993 Sep;161(3):639-41. doi: 10.2214/ajr.161.3.8352124.
Ronchera-Oms CL, Casillas C, Marti-Bonmati L, Poyatos C, Tomas J, Sobejano A, Jimenez NV. Oral chloral hydrate provides effective and safe sedation in paediatric magnetic resonance imaging. J Clin Pharm Ther. 1994 Aug;19(4):239-43. doi: 10.1111/j.1365-2710.1994.tb00680.x.
Hall JE, Uhrich TD, Barney JA, Arain SR, Ebert TJ. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000 Mar;90(3):699-705. doi: 10.1097/00000539-200003000-00035.
Other Identifiers
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CCHMC 2009-0514
Identifier Type: -
Identifier Source: org_study_id
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