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

Not Applicable

Completed

• Conditions: Anesthesia; Parkinson Disease

• Registration Number: NCT04361188
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Primary Completion: 2020-09-30
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scores' change of Unified Parkinson's Rating Scale (part III/motor part)	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

Name	Time	Method
Scores' change of Montreal Cognitive Assessment	Before and six-month after DBS.	Compares the scores' change of Montreal Cognitive Assessment between the two groups.
Dosage of Anesthetic Drugs	Within surgery.	Compares the dosage of anesthetic between the two groups.
Rates of Adverse Events	Intra-operative.	Compares the rates of adverse events between the two groups.
Wake-up Time	Within surgery.	Compares the wake-up time between the two groups.
Hoehn&Yahr	Before surgery.	Compares the Hoehn\&Yahr classification between the two groups' patients.
Scores' change of 39-item Parkinson's Disease Questionnaire	Before and six-month after DBS.	Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.
Change of Levodopa Equivalent Dose	Before and six-month after DBS.	Compares the change of Levodopa equivalent dose between the two groups.
Patients' Satisfaction(Visual Analogue Scale)	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.
Scores' change of Mini-mental State Examination	Before and six-month after DBS.	Compares the scores' change of Mini-mental State Examination between the two groups.
Surgical Time	Within surgery.	Compares the surgical time between the two groups.
Scores' change of Hamilton Anxiety Scale	Before and six-month after DBS.	Compares the scores' change of Hamilton Anxiety Scale between the two groups.
Scores' change of Hamilton Depression Scale	Before and six-month after DBS.	Compares the scores' change of Hamilton Depression Scale between the two groups.

Trial Locations

Locations (1)

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China