UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia
NCT ID: NCT04361188
Last Updated: 2021-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-11-01
2021-05-31
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
SCREENING
TRIPLE
Study Groups
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MAC anesthesia group
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
MAC anesthesia
Patients receives DBS under monitored anesthesia care.
AAA anesthesia group
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
AAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.
Interventions
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MAC anesthesia
Patients receives DBS under monitored anesthesia care.
AAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of primary Parkinson's disease
* Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.
Exclusion Criteria
* Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
* Previous functional neurosurgery: DBS, thalamic incision, etc.
18 Years
ALL
No
Sponsors
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Shenzhen Second People's Hospital
OTHER
Responsible Party
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ZhiHeng Liu
Head of Anesthesiology
Principal Investigators
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Liu Zhiheng, Doctor
Role: STUDY_CHAIR
Anesthesia department of Shenzhen Second People's Hospital
Locations
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Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Countries
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References
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Ho AL, Pendharkar AV, Brewster R, Martinez DL, Jaffe RA, Xu LW, Miller KJ, Halpern CH. Frameless Robot-Assisted Deep Brain Stimulation Surgery: An Initial Experience. Oper Neurosurg. 2019 Oct 1;17(4):424-431. doi: 10.1093/ons/opy395.
Kulikov A, Lubnin A. Anesthesia for awake craniotomy. Curr Opin Anaesthesiol. 2018 Oct;31(5):506-510. doi: 10.1097/ACO.0000000000000625.
Krauss P, Marahori NA, Oertel MF, Barth F, Stieglitz LH. Better Hemodynamics and Less Antihypertensive Medication: Comparison of Scalp Block and Local Infiltration Anesthesia for Skull-Pin Placement in Awake Deep Brain Stimulation Surgery. World Neurosurg. 2018 Dec;120:e991-e999. doi: 10.1016/j.wneu.2018.08.210. Epub 2018 Sep 7.
Kochanski RB, Sani S. Awake versus Asleep Deep Brain Stimulation Surgery: Technical Considerations and Critical Review of the Literature. Brain Sci. 2018 Jan 19;8(1):17. doi: 10.3390/brainsci8010017.
Ho AL, Ali R, Connolly ID, Henderson JM, Dhall R, Stein SC, Halpern CH. Awake versus asleep deep brain stimulation for Parkinson's disease: a critical comparison and meta-analysis. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):687-691. doi: 10.1136/jnnp-2016-314500. Epub 2017 Mar 1.
Chen T, Mirzadeh Z, Chapple KM, Lambert M, Shill HA, Moguel-Cobos G, Troster AI, Dhall R, Ponce FA. Clinical outcomes following awake and asleep deep brain stimulation for Parkinson disease. J Neurosurg. 2018 Mar 16;130(1):109-120. doi: 10.3171/2017.8.JNS17883. Epub 2018 Mar 16.
Chen T, Mirzadeh Z, Chapple KM, Lambert M, Evidente VGH, Moguel-Cobos G, Oravivattanakul S, Mahant P, Ponce FA. Intraoperative test stimulation versus stereotactic accuracy as a surgical end point: a comparison of essential tremor outcomes after ventral intermediate nucleus deep brain stimulation. J Neurosurg. 2018 Aug;129(2):290-298. doi: 10.3171/2017.3.JNS162487. Epub 2017 Oct 13.
Sheshadri V, Rowland NC, Mehta J, Englesakis M, Manninen P, Venkatraghavan L. Comparison of General and Local Anesthesia for Deep Brain Stimulator Insertion: A Systematic Review. Can J Neurol Sci. 2017 Nov;44(6):697-704. doi: 10.1017/cjn.2017.224. Epub 2017 Sep 18.
Grant R, Gruenbaum SE, Gerrard J. Anaesthesia for deep brain stimulation: a review. Curr Opin Anaesthesiol. 2015 Oct;28(5):505-10. doi: 10.1097/ACO.0000000000000230.
Erickson KM, Cole DJ. Anesthetic considerations for awake craniotomy for epilepsy and functional neurosurgery. Anesthesiol Clin. 2012 Jun;30(2):241-68. doi: 10.1016/j.anclin.2012.05.002. Epub 2012 Jul 3.
Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11.
Other Identifiers
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FS20191119007
Identifier Type: -
Identifier Source: org_study_id
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