General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
Primary Purpose
Chronic Subdural Hematoma
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
All General anesthesia
All Locoregional anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring chronic subdural hematoma, general anesthesia, locoregional anesthesia, length of stay
Eligibility Criteria
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
Sites / Locations
- Remi HestinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
All General anesthesia
All Locoregional anesthesia
Arm Description
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
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
Outcomes
Primary Outcome Measures
postoperative theoretical length of stay
Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist
Secondary Outcome Measures
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)
Rates of postoperative surgical complications
acute subdural hematoma; surgical site infection; hydrocephalus
Postoperative medical complications rate
infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other
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)
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.
Mortality rate at 6 months.
Rate of patients died 6 months after the surgery
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.
Opioid consumption
Amount of opioids used during hospitalization
Admission rate in Intensive care unit
Rate of patients admitted in intensive care unit after surgery
Full Information
NCT ID
NCT03666949
First Posted
June 12, 2018
Last Updated
October 22, 2018
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT03666949
Brief Title
General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
Official Title
NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
chronic subdural hematoma, general anesthesia, locoregional anesthesia, length of stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All General anesthesia
Arm Type
Other
Arm Description
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
Arm Title
All Locoregional anesthesia
Arm Type
Other
Arm Description
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
Intervention Type
Drug
Intervention Name(s)
All General anesthesia
Other Intervention Name(s)
GA
Intervention Description
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
Intervention Name(s)
All Locoregional anesthesia
Other Intervention Name(s)
ALR
Intervention Description
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
Primary Outcome Measure Information:
Title
postoperative theoretical length of stay
Description
Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Modified Rankin score (0-6)
Description
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)
Time Frame
3 month
Title
Rates of postoperative surgical complications
Description
acute subdural hematoma; surgical site infection; hydrocephalus
Time Frame
10 days
Title
Postoperative medical complications rate
Description
infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other
Time Frame
10 days
Title
LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.
Description
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)
Time Frame
baseline
Title
MINI COG: Measurement of postoperative cognitive impairment at 6 months
Description
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.
Time Frame
2 days
Title
Mortality rate at 6 months.
Description
Rate of patients died 6 months after the surgery
Time Frame
6 month
Title
Simple numeric scale for postoperative pain
Description
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.
Time Frame
2 days
Title
Opioid consumption
Description
Amount of opioids used during hospitalization
Time Frame
10 days
Title
Admission rate in Intensive care unit
Description
Rate of patients admitted in intensive care unit after surgery
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HESTIN Remi
Phone
0033648729375
Email
remitiopo@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
KAMGA Hervé
Phone
0033231066756
Email
kamga-h@chu-caen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GABEREL Thomas
Organizational Affiliation
MCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Remi Hestin
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémi HESTIN
Phone
00330648729375
Email
remitiopo@hotmail.com
First Name & Middle Initial & Last Name & Degree
remi hestin
Phone
0648729375
Email
remitiopo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hervé KAMGA
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
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