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UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361188
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
ZhiHeng Liu, Shenzhen Second People's Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Anesthesia Procedure: MAC anesthesia Procedure: AAA anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MAC anesthesia group
Parkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Procedure: MAC anesthesia
Patients receives DBS under monitored anesthesia care.

Active Comparator: AAA anesthesia group
Parkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Procedure: AAA anesthesia
Patients receives DBS under asleep-awake-asleep anesthesia.




Primary Outcome Measures :
  1. Scores' change of Unified Parkinson's Rating Scale (part III/motor part) [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.


Secondary Outcome Measures :
  1. Change of Levodopa Equivalent Dose [ Time Frame: Before and six-month after DBS. ]
    Compares the change of Levodopa equivalent dose between the two groups.

  2. Rates of Adverse Events [ Time Frame: Intra-operative. ]
    Compares the rates of adverse events between the two groups.

  3. Dosage of Anesthetic Drugs [ Time Frame: Within surgery. ]
    Compares the dosage of anesthetic between the two groups.

  4. Wake-up Time [ Time Frame: Within surgery. ]
    Compares the wake-up time between the two groups.

  5. Surgical Time [ Time Frame: Within surgery. ]
    Compares the surgical time between the two groups.

  6. Hoehn&Yahr [ Time Frame: Before surgery. ]
    Compares the Hoehn&Yahr classification between the two groups' patients.

  7. Patients' Satisfaction(Visual Analogue Scale) [ Time Frame: 24 hours after surgery. ]
    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.

  8. Scores' change of 39-item Parkinson's Disease Questionnaire [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.

  9. Scores' change of Mini-mental State Examination [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of Mini-mental State Examination between the two groups.

  10. Scores' change of Montreal Cognitive Assessment [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of Montreal Cognitive Assessment between the two groups.

  11. Scores' change of Hamilton Anxiety Scale [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of Hamilton Anxiety Scale between the two groups.

  12. Scores' change of Hamilton Depression Scale [ Time Frame: Before and six-month after DBS. ]
    Compares the scores' change of Hamilton Depression Scale between the two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361188


Contacts
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Contact: Liu Zhiheng, Doctor 15818585570 15818585570@163.com
Contact: Zheng Sihao, Bachelor 18816791174 zhengc2020@163.com

Locations
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China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China, 518035
Contact: Liu Zhiheng, Doctor    15818585570    15818585570@163.com   
Sponsors and Collaborators
Shenzhen Second People's Hospital
Investigators
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Study Chair: Liu Zhiheng, Doctor Anesthesia department of Shenzhen Second People's Hospital
Publications of Results:

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Responsible Party: ZhiHeng Liu, Head of Anesthesiology, Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT04361188    
Other Study ID Numbers: FS20191119007
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZhiHeng Liu, Shenzhen Second People's Hospital:
Parkinson's disease
UPDRS-III
Deep Brain Stimulation
MAC
AAA
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs