Revision of Deep Brain Stimulator in Patients With Parkinson's Disease

Not Applicable

Not yet recruiting

• Conditions: Pain Management; Regional Anesthesia; Deep Brain Stimulation; Parkinsons Disease

• Registration Number: NCT07176494
• Lead Sponsor: Ankara Etlik City Hospital

Brief Summary

Parkinson's disease is a chronic and progressive neurodegenerative disease that affects the central nervous system, particularly impairing movement control. It is associated with the loss of dopamine-producing cells in the brain and typically occurs in middle age and beyond. Deep brain stimulation (DBS) is considered when symptoms of Parkinson's disease, such as tremors, slowed movements, and muscle rigidity, are not adequately controlled with medications. Selected patients with severe symptoms that do not respond to medical treatment are generally considered for this treatment.

Battery revision surgeries can be performed under general anesthesia or regional anesthesia. Patients undergoing general anesthesia should be cautious about the potential complications of general anesthesia, while those undergoing regional anesthesia should be cautious about the local anesthetic systemic toxicity. Because each method has its own advantages, the choice of anesthesia may vary.

This study aimed to compare postoperative analgesic efficacy and patient satisfaction in patients who underwent surgery under general anesthesia or sedation-assisted battery replacement under regional anesthesia. Both anesthesia methods are routinely used in Parkinson's disease patients undergoing battery replacement.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-09-20
• Primary Completion: 2026-07-05
• Study Completion: 2026-07-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Those aged 40-85
• Those with an ASA score of I-II-III
• Those with a body mass index (BMI) between 18-30

Exclusion Criteria

• Those under 40 and over 85
• Those with an ASA score of IV or higher
• Those with a BMI of under 18 and over 30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score	up to 24 hours	Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest and when coughing. Pain assessment will be made at 0, 1, 6, 12, 18, and 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	postoperative 24th hour	Patient satisfaction will be evaluated using a Likert scale.Evaluation will be made using a 5-point Likert scale (1= I am not satisfied at all - 5= I am very satisfied).
Need for additional analgesics	postoperative 24th hour	Additional analgesic need will be assessed

Trial Locations

Locations (1)

Ankara Etlik City Hospital; Ankara, Yenimahalle\Ankara, Turkey (Türkiye)