Sleep Apnea, ObstructivePhase 4NCT01344759

Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

A Phase 4 study testing Dexmedetomidine and Propofol in people with Sleep Apnea, Obstructive, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 12 months to 25 years
Conditions the study is for: Sleep Apnea, Obstructive
What is being tested?: Dexmedetomidine and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Nov 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea

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.

Read the 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.

Conditions: Sleep Apnea, Obstructive
Being tested: Dexmedetomidine, Propofol
Keywords: Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia
Medical subject headings: Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
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.
PropofolDrug
Also called Diprivan
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.

Study groups in NCT01344759
Study group	Role	What they receive
Propofol	Active comparator	Not described Receives: Drug: Propofol
Dexmedetomidine	Active comparator	Not described Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Cross Sectional Area of the Pharyngeal Airway
The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.
Measured: during MRI within first 10 minutes of scanning

Secondary outcomes (4)

Obstructive Index Until Recovery Room Discharge
The Obstructive Index is a count of the obstructive apnea events per hour of sleep
Measured: During MRI and until recovery room discharge - approximately 30-250 minutes
Respiratory Disturbance Index
The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
Measured: During MRI and until recovery room discharge - approximately 30-250 minutes
Needed Artificial Airway
This is the count of the number of patients who needed an artificial airway.
Measured: During MRI and until recovery room discharge - approximately 30-250 minutes
Room Air SpO2
The patient's oxygen saturation on room air.
Measured: During MRI and until recovery room discharge - approximately 30-250 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Nov 2011

First posted29 Apr 2011 (estimated)
Study startJun 2009
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01344759
Sponsor's protocol ID: CCHMC 2009-0514
Status last verified: Aug 2018
First submitted: 21 Apr 2011
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1213/01.ane.0000216293.16613.15.
PubMed 16790626
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.
PubMed 10910487
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.
PubMed 12826844
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.
PubMed 9356115
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.
PubMed 2568769
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.
PubMed 8688266
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.
PubMed 2765337
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.
PubMed 6629915
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.
PubMed 2024847
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.
PubMed 1817614
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.
PubMed 14440737
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.
PubMed 9803430
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.
PubMed 11930064
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.
PubMed 15208134
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.
PubMed 14693585

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Sleep Apnea, Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT01344759
Acronym / sponsor ID: CCHMC 2009-0514
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: Jun 2009
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 23 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Propofol	Active comparator	Drug: Propofol
Dexmedetomidine	Active comparator	Drug: Dexmedetomidine

Who may qualify

Ages: 12 months to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineAlso: PrecedexOnce 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.	Drug	Dexmedetomidine
PropofolAlso: DiprivanOnce 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.	Drug	Propofol

Primary outcome

Cross Sectional Area of the Pharyngeal Airway
Time frame: during MRI within first 10 minutes of scanning
The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.

4 secondary outcomes

Obstructive Index Until Recovery Room Discharge
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Respiratory Disturbance Index
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Needed Artificial Airway
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Room Air SpO2
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes

Results and safety

Results posted to the registry on 23 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Propofol	30	30
Dexmedetomidine	30	28

Primary outcome: Cross Sectional Area of the Pharyngeal Airway

Time frame: during MRI within first 10 minutes of scanning. Median (95% Confidence Interval). Unit: mm^2

Measure	Propofol n = 30	Dexmedetomidine n = 28
Low Dose Sedative, Nasopharyngeal measurement	239.9 (185.4 to 267.2)	178.5 (148.5 to 222.4)
High Dose Sedative, Nasopharyngeal measurement	201.6 (148.9 to 291.7)	235.4 (145.0 to 258.8)
Low Dose Sedative, Retroglossal measurement	115.1 (67.8 to 167.0)	120.9 (63.6 to 179.5)
High dose sedative, Retroglossal measurement	108.1 (53.6 to 134.4)	120.5 (50.1 to 178.4)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Propofol	0 of 30 (0%)	0 of 30 (0%)	Not reported
Dexmedetomidine	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): Failure to standardize mouth opening, due to stimulation of the subject during manipulation of the mouth No baseline measurements were obtained while awake Many patients had Downs syndrome so the results may not apply across all patients with OSA

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16790626Mason 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.
Background: PubMed 10910487Ebert 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.
Background: PubMed 12826844Talke 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.
Background: PubMed 9356115Talke 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.
Background: PubMed 2568769Doze 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.
Background: PubMed 8688266Drummond 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.
Background: PubMed 2765337Drummond GB. Influence of thiopentone on upper airway muscles. Br J Anaesth. 1989 Jul;63(1):12-21. doi: 10.1093/bja/63.1.12.
Background: PubMed 6629915Hwang 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.
Background: PubMed 2024847Hudgel 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.
Background: PubMed 1817614Nandi 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.
Background: PubMed 14440737SAFAR 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.
Background: PubMed 9803430Litman 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.

Related trials for Sleep Apnea, Obstructive

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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamed Mahmoud, MD principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Propofol in people with Sleep Apnea, Obstructive, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cross Sectional Area of the Pharyngeal Airway (time frame: during MRI within first 10 minutes of scanning). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01344759, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.