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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
190
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.
Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .
Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGIncidence of intraoperative body movement
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.
Time frame: During the surgery
Neurological function
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.
Time frame: at discharge and 6 months after operation
Recurrence rate at 6 months after surgery
Rate of reoperations
Time frame: From operation up to 6 months postoperatively
Conversion to general anesthesia
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.
Time frame: During the surgery
Intraoperative awareness
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)?
Time frame: 1 day after surgery
Postoperative delirium
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).
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Time frame: 1-5 days after surgery