Clinical trial NCT03666949: General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
Official title: NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: chronic subdural hematoma
general anesthesia
locoregional anesthesia
length of stay
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: postoperative theoretical length of stay
timeFrame: 10 days
Secondary outcomes:
measure: Modified Rankin score (0-6)
timeFrame: 3 month
measure: Rates of postoperative surgical complications
timeFrame: 10 days
measure: Postoperative medical complications rate
timeFrame: 10 days
measure: LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.
timeFrame: baseline
measure: MINI COG: Measurement of postoperative cognitive impairment at 6 months
timeFrame: 2 days
measure: Mortality rate at 6 months.
timeFrame: 6 month
measure: Simple numeric scale for postoperative pain
timeFrame: 2 days
measure: Opioid consumption
timeFrame: 10 days
measure: Admission rate in Intensive care unit
timeFrame: 3 month
Other outcomes:
Locations:
city: Caen
country: France
facility: Remi Hestin
state: Calvados
Study officials:
affiliation: MCU
name: GABEREL Thomas
role: PRINCIPAL_INVESTIGATOR
References: