General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Drug: All General anesthesia; Drug: All 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Recruiting
      • Remi Hestin
      • Contact: Rémi HESTIN; Phone Number: 00330648729375; Email: remitiopo@hotmail.com
      • Contact: remi hestin; Phone Number: 0648729375; Email: remitiopo@hotmail.com
      • Principal Investigator: Hervé KAMGA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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; Other Names: GA
Other: All Locoregional anesthesia; Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block	Drug: All Locoregional anesthesia; Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block; Other Names: ALR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative theoretical length of stay	Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rates of postoperative surgical complications	acute subdural hematoma; surgical site infection; hydrocephalus	10 days
Postoperative medical complications rate	infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other	10 days
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
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
Mortality rate at 6 months.	Rate of patients died 6 months after the surgery	6 month
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
Opioid consumption	Amount of opioids used during hospitalization	10 days
Admission rate in Intensive care unit	Rate of patients admitted in intensive care unit after surgery	3 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: GABEREL Thomas, MCU

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: general anesthesia; length of stay; locoregional anesthesia; chronic subdural hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: NEURANESTH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No