General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

NCT03666949 | Unknown

• 1 other identifier: NEURANESTH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

chronic subdural hematoma; general anesthesia; locoregional anesthesia; length of stay

Outcome Measures

Primary Outcomes (1)

• postoperative theoretical length of stay

  Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist

  10 days

Secondary Outcomes (9)

• Modified Rankin score (0-6)

  3 month

• Rates of postoperative surgical complications

  10 days

• Postoperative medical complications rate

  10 days

• LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.

  baseline

• MINI COG: Measurement of postoperative cognitive impairment at 6 months

  2 days

Study Arms (2)

All General anesthesia

OTHER

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

All Locoregional anesthesia

OTHER

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

Drug: All Locoregional anesthesia

Interventions

All General anesthesia 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

Also known as: GA

All General anesthesia

All Locoregional anesthesia DRUG

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

Also known as: ALR

All Locoregional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subdural chronic hematoma uni or bilateral
• Obtaining an oral consent
• french speaker
• affilliation to French social security

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Remi Hestin

Caen, Calvados, 14000, France

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• GABEREL Thomas

  MCU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HESTIN Remi

CONTACT

0033648729375; remitiopo@hotmail.com

KAMGA Hervé

CONTACT

0033231066756; kamga-h@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: September 12, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-05

Locations

FR (1)