Back to resultsUPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia
Primary Purpose
Parkinson Disease, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MAC anesthesia
AAA anesthesia
Sponsored by
About this trial
This is an interventional screening trial for Parkinson Disease focused on measuring Parkinson's disease, UPDRS-III, Deep Brain Stimulation, MAC, AAA
Eligibility Criteria
Inclusion Criteria:
- Age greater than 18 years old
- Diagnosis of primary Parkinson's disease
- Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.
Exclusion Criteria:
- Refusal to Participate in the research
- Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
- Previous functional neurosurgery: DBS, thalamic incision, etc.
Sites / Locations
- Shenzhen Second People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MAC anesthesia group
AAA anesthesia group
Arm Description
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of Levodopa Equivalent Dose
Compares the change of Levodopa equivalent dose between the two groups.
Rates of Adverse Events
Compares the rates of adverse events between the two groups.
Dosage of Anesthetic Drugs
Compares the dosage of anesthetic between the two groups.
Wake-up Time
Compares the wake-up time between the two groups.
Surgical Time
Compares the surgical time between the two groups.
Hoehn&Yahr
Compares the Hoehn&Yahr classification between the two groups' patients.
Patients' Satisfaction(Visual Analogue Scale)
Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction.
Scores' change of 39-item Parkinson's Disease Questionnaire
Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.
Scores' change of Mini-mental State Examination
Compares the scores' change of Mini-mental State Examination between the two groups.
Scores' change of Montreal Cognitive Assessment
Compares the scores' change of Montreal Cognitive Assessment between the two groups.
Scores' change of Hamilton Anxiety Scale
Compares the scores' change of Hamilton Anxiety Scale between the two groups.
Scores' change of Hamilton Depression Scale
Compares the scores' change of Hamilton Depression Scale between the two groups.
Full Information
NCT ID
NCT04361188
First Posted
April 21, 2020
Last Updated
August 16, 2021
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04361188
Brief Title
UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia
Official Title
UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen Second People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Anesthesia
Keywords
Parkinson's disease, UPDRS-III, Deep Brain Stimulation, MAC, AAA
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MAC anesthesia group
Arm Type
Experimental
Arm Description
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Arm Title
AAA anesthesia group
Arm Type
Active Comparator
Arm Description
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Intervention Type
Procedure
Intervention Name(s)
MAC anesthesia
Intervention Description
Patients receives DBS under monitored anesthesia care.
Intervention Type
Procedure
Intervention Name(s)
AAA anesthesia
Intervention Description
Patients receives DBS under asleep-awake-asleep anesthesia.
Primary Outcome Measure Information:
Title
Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
Description
Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.
Time Frame
Before and six-month after DBS.
Secondary Outcome Measure Information:
Title
Change of Levodopa Equivalent Dose
Description
Compares the change of Levodopa equivalent dose between the two groups.
Time Frame
Before and six-month after DBS.
Title
Rates of Adverse Events
Description
Compares the rates of adverse events between the two groups.
Time Frame
Intra-operative.
Title
Dosage of Anesthetic Drugs
Description
Compares the dosage of anesthetic between the two groups.
Time Frame
Within surgery.
Title
Wake-up Time
Description
Compares the wake-up time between the two groups.
Time Frame
Within surgery.
Title
Surgical Time
Description
Compares the surgical time between the two groups.
Time Frame
Within surgery.
Title
Hoehn&Yahr
Description
Compares the Hoehn&Yahr classification between the two groups' patients.
Time Frame
Before surgery.
Title
Patients' Satisfaction(Visual Analogue Scale)
Description
Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction.
Time Frame
24 hours after surgery.
Title
Scores' change of 39-item Parkinson's Disease Questionnaire
Description
Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.
Time Frame
Before and six-month after DBS.
Title
Scores' change of Mini-mental State Examination
Description
Compares the scores' change of Mini-mental State Examination between the two groups.
Time Frame
Before and six-month after DBS.
Title
Scores' change of Montreal Cognitive Assessment
Description
Compares the scores' change of Montreal Cognitive Assessment between the two groups.
Time Frame
Before and six-month after DBS.
Title
Scores' change of Hamilton Anxiety Scale
Description
Compares the scores' change of Hamilton Anxiety Scale between the two groups.
Time Frame
Before and six-month after DBS.
Title
Scores' change of Hamilton Depression Scale
Description
Compares the scores' change of Hamilton Depression Scale between the two groups.
Time Frame
Before and six-month after DBS.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age greater than 18 years old
Diagnosis of primary Parkinson's disease
Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.
Exclusion Criteria:
Refusal to Participate in the research
Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
Previous functional neurosurgery: DBS, thalamic incision, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Zhiheng, Doctor
Organizational Affiliation
Anesthesia department of Shenzhen Second People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30629245
Citation
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 (Hagerstown). 2019 Oct 1;17(4):424-431. doi: 10.1093/ons/opy395.
Results Reference
result
PubMed Identifier
29994938
Citation
Kulikov A, Lubnin A. Anesthesia for awake craniotomy. Curr Opin Anaesthesiol. 2018 Oct;31(5):506-510. doi: 10.1097/ACO.0000000000000625.
Results Reference
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PubMed Identifier
30196173
Citation
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.
Results Reference
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PubMed Identifier
29351243
Citation
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.
Results Reference
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PubMed Identifier
28250028
Citation
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.
Results Reference
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PubMed Identifier
29547091
Citation
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.
Results Reference
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PubMed Identifier
29027853
Citation
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.
Results Reference
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PubMed Identifier
28920562
Citation
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.
Results Reference
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PubMed Identifier
26308514
Citation
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.
Results Reference
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PubMed Identifier
22901609
Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia
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