RecruitingNot ApplicableNCT07176494

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

Revision of Deep Brain Stimulator in Patients With Parkinson's Disease: A Comparison of Perioperative Characteristics of Regional and General Anesthesia


Sponsor

Ankara Etlik City Hospital

Enrollment

50 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different anesthesia-related outcomes in Parkinson's disease patients who are having their deep brain stimulator (DBS) device revised or replaced — a surgery used to manage motor symptoms like tremor and rigidity. **You may be eligible if...** - You are between 40 and 85 years old - You have a Parkinson's disease diagnosis and are scheduled for deep brain stimulator revision surgery - You have an ASA physical status score of I, II, or III (meaning generally healthy to having some controlled health conditions) - Your body mass index (BMI) is between 18 and 30 **You may NOT be eligible if...** - You are younger than 40 or older than 85 - You have an ASA score of IV or higher, indicating severe systemic disease - Your BMI is below 18 (underweight) or above 30 (obese) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPatients who underwent surgery under general anesthesia

Patients undergoing surgery under general anesthesia will undergo general anesthesia induction. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.

PROCEDUREPatients who underwent surgery under regional anesthesia

25 cc (15 cc 0.5% bupivacaine + 5 cc 2% lidocaine + 5 cc isotonic) local anesthetic solution is prepared. 10 cc of the medication is administered into the interpectoral plane, and 15 cc into the pectoserratus plane. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia.


Locations(1)

Ankara Etlik City Hospital

Ankara, Yenimahalle\Ankara, Turkey (Türkiye)

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NCT07176494


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