General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

Not Applicable

• Conditions: Chronic Subdural Hematoma
• Interventions: Drug: All General anesthesia; Drug: All Locoregional anesthesia

• Registration Number: NCT03666949
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Status Verified: 2018-05
• Study Start: 2018-05-01
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All General anesthesia	All General anesthesia	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
All Locoregional anesthesia	All Locoregional anesthesia	Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block

Primary Outcome Measures

Name	Time	Method
postoperative theoretical length of stay	10 days	Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist

Secondary Outcome Measures

Name	Time	Method
MINI COG: Measurement of postoperative cognitive impairment at 6 months	2 days	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.
Modified Rankin score (0-6)	3 month	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)
LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.	baseline	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: 1. Strongly disagree (worst score); 2. Disagree; 3. Neither agree nor disagree; 4. Agree; 5. Strongly agree (best score)
Rates of postoperative surgical complications	10 days	acute subdural hematoma; surgical site infection; hydrocephalus
Postoperative medical complications rate	10 days	infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other
Mortality rate at 6 months.	6 month	Rate of patients died 6 months after the surgery
Simple numeric scale for postoperative pain	2 days	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.
Opioid consumption	10 days	Amount of opioids used during hospitalization
Admission rate in Intensive care unit	3 month	Rate of patients admitted in intensive care unit after surgery

Trial Locations

Locations (1)

Remi Hestin; 🇫🇷 Caen, Calvados, France