UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial
Sponsor study identifier
interventional
30
1 country
1
Study Start
November 1, 2019
Actual (reported)Primary Completion
September 30, 2020
Actual (reported)Study Completion
May 31, 2021
Actual (reported)Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2019
Actual (reported)April 21, 2020
Actual (reported)April 24, 2020
Actual (reported)September 30, 2020
Actual (reported)May 31, 2021
Actual (reported)Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.
Before and six-month after DBS.
Change of Levodopa Equivalent Dose
Before and six-month after DBS.
Rates of Adverse Events
Intra-operative.
Dosage of Anesthetic Drugs
Within surgery.
Wake-up Time
Within surgery.
Surgical Time
Within surgery.
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Patients receives DBS under monitored anesthesia care.
Patients receives DBS under asleep-awake-asleep anesthesia.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
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.
Liu Zhiheng, Doctor
Anesthesia department of Shenzhen Second People's Hospital
30 participants (actual enrollment reported by the registry).
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
November 1, 2019
Actual (reported)Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
Contact the study team to confirm eligibility.
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.
Primary Completion
September 30, 2020
Actual (reported)Study Completion
May 31, 2021
Actual (reported)Last Updated
August 17, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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