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Recruiting NCT07176494

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

No phase Interventional Pain Management Regional Anesthesia Deep Brain Stimulation Parkinsons Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patients who underwent surgery under general anesthesia, Patients who underwent surgery under regional anesthesia.
Who it may be relevant to
Registry conditions: Pain Management, Regional Anesthesia, Deep Brain Stimulation, Parkinsons Disease. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Patients 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.
  • Procedure Patients 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.

Primary outcome measures

  • Pain score [Time frame: up to 24 hours]
Secondary outcome measures (2)
  • Patient Satisfaction [Time frame: postoperative 24th hour]
  • Need for additional analgesics [Time frame: postoperative 24th hour]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

Identifiers

NCT: NCT07176494 · AnkaraEtlik1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗