Clinical trial NCT05888389: Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH
Official title: Safety of Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Burr Hole Craniostomy With Drainage for Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Anesthesia
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of intraoperative body movement
timeFrame: During the surgery
Secondary outcomes:
measure: Neurological function
timeFrame: at discharge and 6 months after operation
measure: Recurrence rate at 6 months after surgery
timeFrame: From operation up to 6 months postoperatively
measure: Conversion to general anesthesia
timeFrame: During the surgery
measure: Intraoperative awareness
timeFrame: 1 day after surgery
measure: Postoperative delirium
timeFrame: 1-5 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Weiming Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Yuming Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong HM, Woo XL, Goh CH, Chee PHC, Adenan AH, Tan PCS, Wong ASH. Chronic Subdural Hematoma Drainage Under Local Anesthesia with Sedation versus General Anesthesia and Its Outcome. World Neurosurg. 2022 Jan;157:e276-e285. doi: 10.1016/j.wneu.2021.10.074. Epub 2021 Oct 11.
citation: Ashry A, Al-Shami H, Gamal M, Salah AM. Local anesthesia versus general anesthesia for evacuation of chronic subdural hematoma in elderly patients above 70 years old. Surg Neurol Int. 2022 Jan 12;13:13. doi: 10.25259/SNI_425_2021. eCollection 2022.
citation: Liu HY, Yang LL, Dai XY, Li ZP. Local anesthesia with sedation and general anesthesia for the treatment of chronic subdural hematoma: a systematic review and meta-analysis. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1625-1631. doi: 10.26355/eurrev_202203_28230.