Patients who underwent surgery und… for Parkinson's (NCT07176494)

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?
You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
How long does the trial last?
This trial is estimated to last approximately 9 months.
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.
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.
Will I get a placebo in this trial?
There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Surgical procedure (invasive); Brain surgery / implanted device (invasive); Injection (minimally invasive); Ultrasound (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov