Clinical trial NCT04361188: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Anesthesia
Keywords: Parkinson's disease
UPDRS-III
Deep Brain Stimulation
MAC
AAA
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Scores' change of Unified Parkinson's Rating Scale (part III/motor part)
timeFrame: Before and six-month after DBS.
Secondary outcomes:
measure: Change of Levodopa Equivalent Dose
timeFrame: Before and six-month after DBS.
measure: Rates of Adverse Events
timeFrame: Intra-operative.
measure: Dosage of Anesthetic Drugs
timeFrame: Within surgery.
measure: Wake-up Time
timeFrame: Within surgery.
measure: Surgical Time
timeFrame: Within surgery.
measure: Hoehn&Yahr
timeFrame: Before surgery.
measure: Patients' Satisfaction(Visual Analogue Scale)
timeFrame: 24 hours after surgery.
measure: Scores' change of 39-item Parkinson's Disease Questionnaire
timeFrame: Before and six-month after DBS.
measure: Scores' change of Mini-mental State Examination
timeFrame: Before and six-month after DBS.
measure: Scores' change of Montreal Cognitive Assessment
timeFrame: Before and six-month after DBS.
measure: Scores' change of Hamilton Anxiety Scale
timeFrame: Before and six-month after DBS.
measure: Scores' change of Hamilton Depression Scale
timeFrame: Before and six-month after DBS.
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Anesthesia department of Shenzhen Second People's Hospital
name: Liu Zhiheng, Doctor
role: STUDY_CHAIR
References:
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