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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: General Anesthesia; Procedure: Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liang Wu, M.D.; Phone Number: +8601059975450; Email: jasewl@sina.com
• Study Contact Backup: Name: Shu Li, M.D.; Phone Number: +8601059976658; Email: lishu@bjtth.org

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Tiantan Hospital, Capital Medical University
      • Contact: Liang Wu, M.D.; Phone Number: +8615001333582; Email: jasewl@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia (GA); The GA group will receive general anesthesia.	Procedure: General Anesthesia; Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .
Experimental: Cranial nerve block anesthesia combined with sedative anesthesia (CNB-D); The CNB-D group will receive cranial nerve block anesthesia combined with sedative anesthesia	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate at 6 months after surgery	Rate of reoperations	From operation up to 6 months postoperatively
Neurological function	Measured using Markwalder Grading Scale and the Modified Rankin Scale. Markwalder Grading Scale ranges from grade 0 to 4, and the Modified Rankin Scale score ranges from 0 to 6.	at discharge and 6 months after operation
Conversion to general anesthesia	For the nerve block anesthesia combined with sedative anesthesia group, general anesthesia is performed if uncontrolled body movements still exist after opioid and sedative supplement.	During the surgery
Intraoperative awareness	Measured with the Brice questionnaire. Evaluate Intraoperative awareness through the following 6 questions：1. What is the last thing you remember before going to sleep (please tick one box)?2. What is the first thing you remember after waking up (please tick one box)?3. Do you remember anything between going to sleep and waking up (please tick box)?4. Did you dream during your procedure (please tick box)?5. Were your dreams disturbing to you (please tick box)?6. What was the worst thing about your operation (please tick box)?	1 day after surgery
Postoperative delirium	POD will be assessed twice a day (before 09:00 and after 16:00) using the Richmond Agitation-Sedation Scale, the Confusion Assessment Method for Intensive Care Unit (CAM-ICU), and the 3- Minute Diagnostic Interview for CAM (3D-CAM).	1-5 days after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Weiming Liu, M.D., Beijing Tiantan Hospital; Principal Investigator: Yuming Peng, M.D., Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Drainage; General Anesthesia; Chronic Subdural Hematoma; Nerve Block Anesthesia; Sedative Anesthesia; Burr Hole Craniostomy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Hypnotics and Sedatives
• Other Study ID Numbers: HX-B-2022078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No