General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

NCT ID: NCT03666949

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Chronic Subdural Hematoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

All General anesthesia

Intervention Type DRUG

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

Group Type OTHER

All Locoregional anesthesia

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

All Locoregional anesthesia

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

Intervention Type DRUG

Other Intervention Names

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GA ALR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GABEREL Thomas

Role: PRINCIPAL_INVESTIGATOR

MCU

Locations

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Remi Hestin

Caen, Calvados, France

Site Status RECRUITING

Countries

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France

Central Contacts

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HESTIN Remi

Role: CONTACT

0033648729375

KAMGA Hervé

Role: CONTACT

0033231066756

Facility Contacts

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Rémi HESTIN

Role: primary

00330648729375

remi hestin

Role: backup

0648729375

Other Identifiers

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NEURANESTH

Identifier Type: -

Identifier Source: org_study_id

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