General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

Chronic Subdural Hematoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03666949
• Other study ID #: NEURANESTH
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2018
• Source: University Hospital, Caen
• Contact: HESTIN Remi
• Phone: 0033648729375
• Email: remitiopo[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• 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
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block

Locations

Country	Name	City	State
France	Remi Hestin	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative theoretical length of stay	Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist	10 days
Secondary	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
Secondary	Rates of postoperative surgical complications	acute subdural hematoma; surgical site infection; hydrocephalus	10 days
Secondary	Postoperative medical complications rate	infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other	10 days
Secondary	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
Secondary	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
Secondary	Mortality rate at 6 months.	Rate of patients died 6 months after the surgery	6 month
Secondary	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
Secondary	Opioid consumption	Amount of opioids used during hospitalization	10 days
Secondary	Admission rate in Intensive care unit	Rate of patients admitted in intensive care unit after surgery	3 month