Revision of Deep Brain Stimulator in Patients With Parkinson's Disease
NCT ID: NCT07176494
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-20
2026-07-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Patients who underwent surgery under general anesthesia
These patients will be operated on under general anesthesia. 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.
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.
Patients who underwent surgery under regional anesthesia
These patients will undergo surgery under regional anesthesia. Interpectoral and pectoserratus plane blocks will be applied to these patients. In the block group, bupivacaine and lidocaine are injected using an ultrasound-guided in-plane technique, between the 3rd and 4th ribs, into the interpectoral plane, and into the pectoserratus plane.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Those with an ASA score of I-II-III
* Those with a body mass index (BMI) between 18-30
Exclusion Criteria
* Those with an ASA score of IV or higher
* Those with a BMI of under 18 and over 30
40 Years
85 Years
ALL
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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İbrahim Topcu
Principal Investigator
Locations
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Ankara Etlik City Hospital
Ankara, Yenimahalle\Ankara, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AnkaraEtlik1
Identifier Type: -
Identifier Source: org_study_id
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