RecruitingNot ApplicableNCT05888389

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

Safety of Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Burr Hole Craniostomy With Drainage for Chronic Subdural Hematoma


Sponsor

Beijing Tiantan Hospital

Enrollment

190 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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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 .


Locations(1)

Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT05888389


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