Chronic Subdural HematomaNCT05888389
Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Surgery for CSDH
A study testing Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia and General Anesthesia in people with Chronic Subdural Hematoma and Anesthesia, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Subdural Hematoma, Anesthesia
- What is being tested?
- Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia and General Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Liang Wu, M.D., +8615001333582, jasewl@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma, Anesthesia
- Being tested
- Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia, General Anesthesia
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Nerve Block Anesthesia Combined With Sedative AnesthesiaProcedure or surgery
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.
General AnesthesiaProcedure or surgery
Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia (GA) | Active comparator | The GA group will receive general anesthesia. Receives: 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 Receives: Procedure: Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the surgery
Secondary outcomes (5)
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.
Measured: at discharge and 6 months after operation
Recurrence rate at 6 months after surgery
Rate of reoperations
Measured: From operation up to 6 months postoperatively
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.
Measured: 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)?
Measured: 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).
Measured: 1-5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Apr 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiming Liu, Beijing Tiantan Hospital
- Investigators
- Weiming Liu, M.D., Principal investigator, Beijing Tiantan HospitalYuming Peng, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888389
- Sponsor's protocol ID
- HX-B-2022078
- Status last verified
- Apr 2024
- First submitted
- 7 May 2023
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34648987Ashry 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.
PubMed 35127213Liu 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.
PubMed 35302209
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Nerve Block Anesthesia Combined With Sedative Anesthesia Versus General Anesthesia in Burr Hole Craniostomy With Drainage for Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT05888389
- Acronym / sponsor ID
- HX-B-2022078
- Conditions
- Chronic Subdural Hematoma, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia (GA) | Active comparator | Procedure: General AnesthesiaThe GA group will receive general anesthesia. |
| Cranial nerve block anesthesia combined with sedative anesthesia (CNB-D) | Experimental | Procedure: Cranial Nerve Block Anesthesia Combined With Sedative AnesthesiaThe CNB-D group will receive cranial nerve block anesthesia combined with sedative anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Nerve Block Anesthesia Combined With Sedative AnesthesiaPatients 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. | Procedure or surgery | Cranial nerve block anesthesia combined with sedative anesthesia (CNB-D) |
| General AnesthesiaPatients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium . | Procedure or surgery | General anesthesia (GA) |
Primary outcome
Incidence of intraoperative body movement
Time frame: During the surgery
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.
5 secondary outcomes
Neurological function
Time frame: at discharge and 6 months after operation
Recurrence rate at 6 months after surgery
Time frame: From operation up to 6 months postoperatively
Conversion to general anesthesia
Time frame: During the surgery
Intraoperative awareness
Time frame: 1 day after surgery
Postoperative delirium
Time frame: 1-5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 34648987Wong 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.
- Background: PubMed 35127213Ashry 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.
- Background: PubMed 35302209Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiming Liu, M.D. principal investigator
Beijing Tiantan Hospital
Yuming Peng, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia and General Anesthesia in people with Chronic Subdural Hematoma and Anesthesia, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu Li, M.D. (+8601059976658, lishu@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative body movement (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888389, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.