Comparing nerve block anesthesia with general anesthesia for surgery on chronic subdural hematoma
Safety of Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Burr Hole Craniostomy With Drainage for Chronic Subdural Hematoma
This study is testing if using nerve block anesthesia with sedation is safer and better than general anesthesia for patients having surgery for chronic subdural hematoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05888389 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of nerve block anesthesia combined with sedative anesthesia compared to general anesthesia during burr hole craniostomy for chronic subdural hematoma. It is a prospective, multicenter, randomized controlled trial where patients will be assigned to either receive cranial nerve block with dexmedetomidine sedation or general anesthesia. The primary outcome measured will be the incidence of intraoperative limb movement, while secondary outcomes will assess postoperative delirium, neurological function, and recurrence of hematoma. The trial aims to determine if the nerve block approach can provide a safer alternative to general anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic subdural hematoma and preoperative neurological dysfunction requiring burr hole drainage.
Not a fit: Patients with severe comorbidities, cognitive dysfunction, or those who have previously undergone surgery for chronic subdural hematoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer anesthesia options for patients undergoing surgery for chronic subdural hematoma.
How similar studies have performed: Similar studies have shown promising results with nerve block anesthesia in various surgical settings, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic subdural hematoma with preoperative neurological dysfunction for burr hole drainage; * Age beween 18 to 80 * Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging with hematoma thickness \>1.0cm or midline shift \>1.0 cm. * Written informed consent obtained Exclusion Criteria: * Preoperative unconsciousness (Glasgow Coma Scale\<13, or Markwalder Grade 2-4) or cognitive dysfunction (Mini-Cog≤3, or MMSE≤20) * Preoperative sensory or motor aphasia * Recurrence of hematoma with previous surgery for chronic subdural hematoma. * Previous intracranial surgery or with intracranial lesion * with severe comorbidity or other organ dysfunction * Allergic to anesthetics * Severe coagulopathy or high risk of life-threatening bleeding * Participating in another research
Where this trial is running
Beijing, Beijing
- Tiantan Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Weiming Liu, M.D. — Beijing Tiantan Hospital
- Study coordinator: Shu Li, M.D.
- Email: lishu@bjtth.org
- Phone: +8601059976658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.