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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Subdural Hematoma Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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General anesthesia (GA)

The GA group will receive general anesthesia.

Group Type ACTIVE_COMPARATOR

General Anesthesia

Intervention Type PROCEDURE

Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .

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

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

Group Type EXPERIMENTAL

Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia

Intervention Type PROCEDURE

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.

Interventions

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Cranial 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.

Intervention Type PROCEDURE

General Anesthesia

Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No