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

Shenzhen Second People's Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Enrollment

Conditions

Parkinson Disease Anesthesia

Interventions

MAC anesthesiaPROCEDURE

Patients receives DBS under monitored anesthesia care.

AAA anesthesiaPROCEDURE

Patients receives DBS under asleep-awake-asleep anesthesia.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: Before and six-month after DBS.

Secondary Outcomes

Change of Levodopa Equivalent Dose

Compares the change of Levodopa equivalent dose between the two groups.

Time frame: Before and six-month after DBS.

Rates of Adverse Events

Compares the rates of adverse events between the two groups.

Time frame: Intra-operative.

Dosage of Anesthetic Drugs

Compares the dosage of anesthetic between the two groups.

Time frame: Within surgery.

Wake-up Time

Compares the wake-up time between the two groups.

Time frame: Within surgery.

Surgical Time

Compares the surgical time between the two groups.

Time frame: Within surgery.

Hoehn&Yahr

Compares the Hoehn\&Yahr classification between the two groups' patients.

Time frame: Before surgery.

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.

Data from ClinicalTrials.gov

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