Overview
A prospective, multicenter, randomized controlled trial is designed to evaluate the safety of nerve block anesthesia combined with sedative anesthesia versus general anesthesia during burr hole craniostomy with drainage for chronic subdural hematoma.
Description
This is a prospective, multi-centre, randomised, controlled, single-blinded, non-inferiority trial. Patients with chronic subdural hematoma undergoing burr-hole drainage will be randomly allocated to receive either the cranial nerve block with dexmedetomidine sedation or general anaesthesia. Patients in the cranial nerve block with dexmedetomidine sedation group will receive cranial nerve block with 0.5% ropivacaine and 1% lidocaine mixture according to incision, combined with dexmedetomidine infusion at a rate of 2-4ug/kg for 10 minutes, followed by a continuous infusion of 0.5 to 1ug/kg/h until the end of the operation. Patients in the general anaesthesia group will be induced with propofol or etomidate, sufentanil, rocuronium or cis-atracurium and be maintained with total intravenous anaesthesia. The primary outcome is the incidence of intraoperative limb movement. Secondary outcomes include postoperative delirium within five days after surgery, anaesthesia conversion, postoperative neurological function, intraoperative awareness, and recurrence rate of hematoma within 6 months after surgery.
Eligibility
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