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Search / Trial NCT05888389

Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH

Launched by BEIJING TIANTAN HOSPITAL · Jun 2, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring two different methods of anesthesia to see which is safer for patients undergoing a specific type of brain surgery called burr hole craniostomy, which is done to treat chronic subdural hematoma (CSDH). The trial compares nerve block anesthesia combined with sedation to general anesthesia, which puts patients completely asleep. The goal is to find out if the nerve block method, which numbs the area around the brain while keeping patients more awake, is as safe as the more traditional approach of general anesthesia.

To participate in the trial, patients need to be between 18 and 80 years old and diagnosed with chronic subdural hematoma, confirmed by imaging tests like CT or MRI. They should have some neurological issues before surgery but must not be unconscious or have significant cognitive problems. Participants will receive detailed information about the trial, and their safety will be closely monitored throughout the process. This study is currently recruiting participants from various centers, and it aims to improve the way surgeries for chronic subdural hematoma are performed, ultimately benefiting patients' recovery and overall experience.

Gender

ALL

Eligibility 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

About Beijing Tiantan Hospital

Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Weiming Liu, M.D.

Principal Investigator

Beijing Tiantan Hospital

Yuming Peng, M.D.

Principal Investigator

Beijing Tiantan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported