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

NCT05888389 | Recruiting DMC

• 1 other identifier: HX-B-2022078
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence 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.

  During the surgery

Secondary Outcomes (5)

• Neurological function

  at discharge and 6 months after operation

• Recurrence rate at 6 months after surgery

  From operation up to 6 months postoperatively

• Conversion to general anesthesia

  During the surgery

• Intraoperative awareness

  1 day after surgery

• Postoperative delirium

  1-5 days after surgery

Study Arms (2)

General anesthesia (GA)

ACTIVE COMPARATOR

The GA group will receive general anesthesia.

Procedure: General Anesthesia

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

EXPERIMENTAL

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

Procedure: Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia

Interventions

Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia 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.

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

General Anesthesia PROCEDURE

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

General anesthesia (GA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 34648987 BACKGROUND

• 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.

  PMID: 35127213 BACKGROUND

• 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.

  PMID: 35302209 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Weiming Liu, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Yuming Peng, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Li, M.D.

CONTACT

+8601059976658; lishu@bjtth.org

Liang Wu, M.D.

CONTACT

+8601059975450; jasewl@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 5, 2023
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)