Numbing surgical area speeds recovery
- Trial ID
- NCT07176494
- Official Title
- Revision of Deep Brain Stimulator in Patients With Parkinson's Disease: A Comparison of Perioperative Characteristics of Regional and General Anesthesia
- Goal
- Numbing surgical area speeds recovery
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Ankara Etlik City Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Pain Management, Regional Anesthesia, Deep Brain Stimulation, Parkinsons Disease
- Interventions
- Patients who underwent surgery under general anesthesia, Patients who underwent surgery under regional anesthesia
Summary For Families
The trial aims to find out whether using regional anesthesia instead of general anesthesia during revision surgery for deep brain stimulators changes perioperative outcomes like pain control, blood pressure stability, complications, and recovery time. It compares patients who have the surgery under general anesthesia, which makes you fully unconscious, with those who have regional anesthesia, which numbs the surgical area and may let you remain more awake, tracking things like intraoperative stability, postoperative pain, and how quickly you recover. Because anesthesia affects breathing, blood pressure, and how soon you can resume Parkinson medications, the study looks at these practical effects for people on treatments such as levodopa. Adults aged 40 to 85 with an ASA score of I to III and a BMI between 18 and 30 are eligible.
Locations
- Ankara Etlik City Hospital, Ankara, Yenimahalle\Ankara, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Patients who underwent surgery under general anesthesia. The trial aims to find out whether using regional anesthesia instead of general anesthesia during revision surgery for deep brain stimulators changes perioperative outcomes like pain control, blood pressure stability, complications, and recovery time. It compares patients who have the surgery under general anesthesia, which makes you fully unconscious, with those who have regional anesthesia, which numbs the surgical area and may let you remain more awake, tracking things like intraoperative stability, postoperative pain, and how quickly you recover. Because anesthesia affects breathing, blood pressure, and how soon you can resume Parkinson medications, the study looks at these practical effects for people on treatments such as levodopa. Adults aged 40 to 85 with an ASA score of I to III and a BMI between 18 and 30 are eligible.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.