Trial of Awake Burr Hole Craniotomy in Patients with Chronic Subdural Hematoma (ABC-SDH trial I): a safety and feasibility randomized controlled trial
- Conditions
- I62.02
- Registration Number
- DRKS00034040
- Lead Sponsor
- Charité - Universitätsmedizin Berlin, Klinik für Neurochirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Adult patients (age = 18 years)
- Symptomatic and asymptomatic cSDH confirmed by imaging (MRI/CT) that require surgical treatment
- Informed consent of the patient. Only patients capable of giving informed consent will be included.
- No consent for participation
- Bilateral cSDH, both of which require surgical treatment
- Preoperative delirium
- Patients with conditions for which surgery under local or general anaesthesia is contraindicated
o Known allergy to lidocaine or bupivacaine
o Known allergy or contraindication to epinephrine
o Patients with a history of psychiatric disorders that could make awake surgery difficult and jeopardise the patient's safety during surgery (panic disorder/episodic paroxysmal anxiety, claustrophobia)
- Previous participation in this study
- Time interval from admission to surgery > 24 hours
- CSDH in the presence of a CSF shunt
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Recruitment rate; two rates will be examined: 1. all patients who consent (consent rate) and 2. all patients who are then operated on according to their randomisation (surgery rate after randomisation)<br>- Complication rate (up to discharge and 1 month after the operation)
- Secondary Outcome Measures
Name Time Method - Postoperative delirium until discharge from the neurosurgery department, measured every 8 hours by CAM <br>- Glasgow Coma Scale (GCS) at discharge from the neurosurgery department and 1 month after surgery<br>- Markwalder cSDH scale on discharge from the neurosurgery department and 1 month after the operation<br>- Modified Rankin Scale (mRS) at discharge from the neurosurgery department and 1 month after surgery<br>- Barthel Index at discharge from the neurosurgery department and 1 month after surgery<br>- Mortality (1 month after surgery) <br>- Length of stay on the neurosurgical ward <br>- Discharge location from the neurosurgery department<br>- Health economic analysis<br>- In case of non-consent/withdrawal: survey and analysis of the reasons at which point in time and why the patients do not wish to participate