Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea - Full Text View

Purpose

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.

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.

Condition	Intervention	Phase
Sleep Apnea, Obstructive	Drug: Dexmedetomidine Drug: Propofol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Propofol Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:

Cross sectional area of the pharyngeal airway [ Time Frame: during MRI within first 10 minutes of scanning ] [ Designated as safety issue: No ]
The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels (soft palate and base of the tongue).

Secondary Outcome Measures:

Patient obstructive index and airway maintenance until Recovery Room discharge [ Time Frame: during MRI and until Recovery Room discharge - approximately 30 - 250 minutes ] [ Designated as safety issue: No ]
(a) anteroposterior dimension and transverse dimension of the pharyngeal airway of the patients measured at two levels: soft palate and base of the tongue, (b) patient movement during scan,(c) episodes of low oxygen saturation(d) placement of adjunct airway such as oral/nasal airway, laryngeal mask airway or endotracheal tube, (e) examine the relationship between OSA severity and episodes of desaturation and artificial airway placement, (f) PACU discharge time (g) arterial blood pressure and heart rate relative to baseline following dexmedetomidine and propofol.

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Propofol	Drug: 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 Name: Diprivan
Active Comparator: Dexmedetomidine	Drug: 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. Other Name: Precedex

Detailed Description:

Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.

Eligibility

Ages Eligible for Study:	12 Months to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
Subjects must be 12 months to 25 years of age (inclusive)
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:

The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
The subject has a tracheostomy or other mechanical airway device
The subject is not scheduled to receive anesthesia-sedation care for the MRI
The subject has a history or a family (parent or sibling) history of malignant hyperthermia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344759

Contacts

Contact: Mohamed Mahmoud, MD

513636 4408

mohamed.mahmoud@cchmc.org

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Mohamed Mahmoud, MD 513-636-4408 mohamed.mahmoud@cchmc.org
Principal Investigator: Mohamed Mahmoud, MD

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator:

Mohamed Mahmoud, MD

Children's Hospital Medical Center, Cincinnati

More Information

Publications:

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.

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.

Talke P, Lobo E, Brown R. Systemically administered alpha2-agonist-induced peripheral vasoconstriction in humans. Anesthesiology. 2003 Jul;99(1):65-70.

Talke P, Richardson CA, Scheinin M, Fisher DM. Postoperative pharmacokinetics and sympatholytic effects of dexmedetomidine. Anesth Analg. 1997 Nov;85(5):1136-42.

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.

Drummond GB. Comparison of sedation with midazolam and ketamine: effects on airway muscle activity. Br J Anaesth. 1996 May;76(5):663-7.

Drummond GB. Influence of thiopentone on upper airway muscles. Br J Anaesth. 1989 Jul;63(1):12-21.

Hwang JC, St John WM, Bartlett D Jr. Respiratory-related hypoglossal nerve activity: influence of anesthetics. J Appl Physiol. 1983 Sep;55(3):785-92.

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.

Nandi PR, Charlesworth CH, Taylor SJ, Nunn JF, Doré CJ. Effect of general anaesthesia on the pharynx. Br J Anaesth. 1991 Feb;66(2):157-62.

SAFAR P, ESCARRAGA LA, CHANG F. Upper airway obstruction in the unconscious patient. J Appl Physiol. 1959 Sep;14:760-4. 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.

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.

Ibacache ME, Muñoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-3, table of contents.

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.

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.

Mahmoud M, Tyler T, Sadhasivam S. Dexmedetomidine and ketamine for large anterior mediastinal mass biopsy. Paediatr Anaesth. 2008 Oct;18(10):1011-3. 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.

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. 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. 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.

Usher AG, Kearney RA, Tsui BC. Propofol total intravenous anesthesia for MRI in children. Paediatr Anaesth. 2005 Jan;15(1):23-8.

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.

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.

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.

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.

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.

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.

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.

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.

Ronchera-Oms CL, Casillas C, Martí-Bonmatí L, Poyatos C, Tomás J, Sobejano A, Jiménez NV. Oral chloral hydrate provides effective and safe sedation in paediatric magnetic resonance imaging. J Clin Pharm Ther. 1994 Aug;19(4):239-43.

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.

Responsible Party:	Mohamed Mahmoud, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier:	NCT01344759 History of Changes
Other Study ID Numbers:	CCHMC 2009-0514
Study First Received:	April 21, 2011
Last Updated:	April 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Obstructive Sleep Apnea
MRI
Pediatrics

Dexmedetomidine
Propofol
Anesthesia

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on June 17, 2013