An interventional study of Cranial Nerve Block Anesthesia Combined With Sedative Anesthesia and General Anesthesia in Chronic Subdural Hematoma and Anesthesia, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
Among 17 studies in Hematoma, Subdural, Chronic with a site in China — 9 open to participants now, 9 under way, none of them phase 3. Hematoma, Subdural, Chronic · China.
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, this one is the 9th largest by planned enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2024, is one of 12 with no phase, and was the 10th registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 190 is close to the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →9 of the 17 studies in Hematoma, Subdural, Chronic with a site in China are open now.
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 35 Hematoma, Subdural, Chronic studies recruiting now, 26 (74%) set no upper age limit and 1 (3%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →17 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2024.
Median enrollment 200 across the 15 interventional studies, 440 across the 2 observational. Of the 3 that completed or were terminated, 1 (33%) have results posted.
1 of 17 have an industry lead sponsor. The 9 most frequent:
Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Beijing Tiantan Hospital has 6 studies filed under Hematoma, Subdural, Chronic — fewer than ten, so there is no comparison to draw.
2 of the studies in Hematoma, Subdural, Chronic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06401772Huashan HospitalThe Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma | 2026-12 |
| NCT07144423Beijing Tiantan HospitalNeuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma | 2027-07-31 |
Among the 17 studies in Hematoma, Subdural, Chronic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The GA group will receive general anesthesia.
Procedure: General Anesthesia
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.
Patients will be induced with propofol or etomidate, sufentanil , rocuronium or cisatracurium .
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.
Time frame: During the surgery
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.
Time frame: at discharge and 6 months after operation
Recurrence rate at 6 months after surgery
Rate of reoperations
Time frame: 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.
Time frame: 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)?
Time frame: 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).
Time frame: 1-5 days after surgery
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for Jun 2025, 14 months after the start.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
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