General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

Study Overview
=================
Brief Summary
-----------------
This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.

Detailed Description
-----------------
General anesthesia is the most common technique for this surgery. The local anesthesia is less common but it allows to obtain the same surgical result. This last technique being more recent little study compared these two techniques in terms of complications and postoperative consequences. The investigators will randomize patients into two groups (a general anesthesia group and a locoregional anesthesia group). General anesthesia provides complete immobility and optimal surgical comfort but is a source of multiple complications, especially in a population of polypathological and polymedicated elderly patients (which is the population affected by chronic subdural hematomas). Locoregional anesthesia requires special technical training, leads to complete analgesia of the surgical procedure but does not involve complete immobility of the patient, however this technique probably leads to less postoperative complications and allows a more early rehabilitation.

Official Title
-----------------
NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial

Conditions
-----------------
Chronic Subdural Hematoma

Intervention / Treatment
-----------------
* Drug: All General anesthesia
* Drug: All Locoregional anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subdural chronic hematoma uni or bilateral Obtaining an oral consent french speaker affilliation to French social security Exclusion Criteria: Patients agitated or not cooperating, not allowing the realization of a locoregional anesthesia Patients with other intracranial lesions Patients with underlying neurological pathology with a modified Rankin score greater than 1 Pregnant or lactating women Patients under guardianship / curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All General anesthesia<br>Use of a hypnotic(propofol 2.5mg/kg), morphine(remifentanil1yg/kg) and curare(atracurium0.5mg/kg), with the support of orotracheal intubation and mechanical ventilation | Drug: All General anesthesia<br>* Use of a hypnotic(propofol 2.5mg/kg), morphine(remifentanil1yg/kg) and curare(atracurium0.5mg/kg), with the support of orotracheal intubation and mechanical ventilation<br>* Other names: GA;|
| Other: All Locoregional anesthesia<br>Use of a local anesthetic( xylocaine 1%) for the realization of scalp nerve block | Drug: All Locoregional anesthesia<br>* Use of a local anesthetic( xylocaine 1%) for the realization of scalp nerve block<br>* Other names: ALR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative theoretical length of stay | Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin score (0-6) | Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. No symptoms at all 0 (best score) No significant disability despite symptoms; able to carry out all usual duties and activities 1 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 2 Moderate disability; requiring some help, but able to walk without assistance 3 Moderately severe disability; unable to walk and attend to bodily needs without assistance 4 Severe disability; bedridden, incontinent and requiring constant nursing care and attention 5 Dead 6 (worst score) | 3 month | 
| Rates of postoperative surgical complications | acute subdural hematoma; surgical site infection; hydrocephalus | 10 days | 
| Postoperative medical complications rate | infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other | 10 days | 
| LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient. | A Likert scale is a psychometric scale commonly involved in research that employs questionnaires. The format of a typical five-level Likert item, for example, could be: Strongly disagree (worst score) Disagree Neither agree nor disagree Agree Strongly agree (best score) | baseline | 
| MINI COG: Measurement of postoperative cognitive impairment at 6 months | Two components, a 3-item recall test for memory and a simply scored clock drawing test. The test is done just before surgery, in the recovery room and the day after. | 2 days | 
| Mortality rate at 6 months. | Rate of patients died 6 months after the surgery | 6 month | 
| Simple numeric scale for postoperative pain | The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. | 2 days | 
| Opioid consumption | Amount of opioids used during hospitalization | 10 days | 
| Admission rate in Intensive care unit | Rate of patients admitted in intensive care unit after surgery | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic subdural hematoma, general anesthesia, locoregional anesthesia, length of stay