Anesthesia, Chronic Subdural Hematoma
Conditions
Brief summary
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.
Detailed 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.
Interventions
PROCEDURECranial Nerve Block Anesthesia Combined With Sedative Anesthesia
Patients in the nerve block anesthesia combined with sedative anesthesia group will first receive cranial nerve blocks under standard monitoring. At the same time, intravenous dexmedetomidine infusion is started for sedation at a rate of 2-4ug/kg for 10 minutes, followed by a continuous infusion of 0.5-1ug/kg/h until the Richmond Agitation-Sedation Scale (RASS) of -3.
PROCEDUREGeneral Anesthesia
Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative body movement | During the surgery | Intraoperative body movement is defined as those likely to interfere with surgical procedures such as bending of hand and/or leg and movement of head. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological function | at discharge and 6 months after operation | Measured using Markwalder Grading Scale and the Modified Rankin Scale. Markwalder Grading Scale ranges from grade 0 to 4, and the Modified Rankin Scale score ranges from 0 to 6. |
| Recurrence rate at 6 months after surgery | From operation up to 6 months postoperatively | Rate of reoperations |
| Conversion to general anesthesia | During the surgery | For the nerve block anesthesia combined with sedative anesthesia group, general anesthesia is performed if uncontrolled body movements still exist after opioid and sedative supplement. |
| Intraoperative awareness | 1 day after surgery | Measured with the Brice questionnaire. Evaluate Intraoperative awareness through the following 6 questions：1. What is the last thing you remember before going to sleep (please tick one box)?2. What is the first thing you remember after waking up (please tick one box)?3. Do you remember anything between going to sleep and waking up (please tick box)?4. Did you dream during your procedure (please tick box)?5. Were your dreams disturbing to you (please tick box)?6. What was the worst thing about your operation (please tick box)? |
| Postoperative delirium | 1-5 days after surgery | POD will be assessed twice a day (before 09:00 and after 16:00) using the Richmond Agitation-Sedation Scale, the Confusion Assessment Method for Intensive Care Unit (CAM-ICU), and the 3- Minute Diagnostic Interview for CAM (3D-CAM). |
Countries
China
Contacts
Primary ContactShu Li, M.D.
Backup ContactLiang Wu, M.D.
Outcome results
None listed