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

Capital Medical University

Status: Enrolling

Conditions: Chronic Subdural Hematoma; Anesthesia

Treatments: Procedure: Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia; Procedure: General Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05888389

HX-B-2022078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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190 participants in 2 patient groups

General anesthesia (GA)

Active Comparator group

Description:

The GA group will receive general anesthesia.

Treatment:

Procedure: General Anesthesia

Cranial nerve block anesthesia combined with sedative anesthesia (CNB-D)

Experimental group

Description:

The CNB-D group will receive cranial nerve block anesthesia combined with sedative anesthesia

Treatment:

Procedure: Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia