Revision of Deep Brain Stimulator in Patients With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorAnkara Etlik City Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Those aged 40-85
Those with an ASA score of I-II-III
Those with a body mass index (BMI) between 18-30
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Patients who underwent surgery under general anesthesia
Procedure/SurgeryPatients 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
Procedure/Surgery25 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Patients who underwent surgery under general anesthesiaActive comparator 1 intervention
Group B: Patients who underwent surgery under regional anesthesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain score
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.
Time frame
up to 24 hoursSecondary outcomes
1
Patient Satisfaction
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).
Time frame
postoperative 24th hour2
Need for additional analgesics
Additional analgesic need will be assessed
Time frame
postoperative 24th hourSponsors and contacts
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Source ClinicalTrials.gov