- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666949
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: HESTIN Remi
- Phone Number: 0033648729375
- Email: remitiopo@hotmail.com
Study Contact Backup
- Name: KAMGA Hervé
- Phone Number: 0033231066756
- Email: kamga-h@chu-caen.fr
Study Locations
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Calvados
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Caen, Calvados, France, 14000
- Recruiting
- Remi Hestin
-
Contact:
- Rémi HESTIN
- Phone Number: 00330648729375
- Email: remitiopo@hotmail.com
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Contact:
- remi hestin
- Phone Number: 0648729375
- Email: remitiopo@hotmail.com
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Principal Investigator:
- Hervé KAMGA
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
|
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:
|
Other: All Locoregional anesthesia
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
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Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative theoretical length of stay
Time Frame: 10 days
|
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)
Time Frame: 3 month
|
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
Time Frame: 10 days
|
acute subdural hematoma; surgical site infection; hydrocephalus
|
10 days
|
Postoperative medical complications rate
Time Frame: 10 days
|
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.
Time Frame: baseline
|
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:
|
baseline
|
MINI COG: Measurement of postoperative cognitive impairment at 6 months
Time Frame: 2 days
|
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.
Time Frame: 6 month
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Rate of patients died 6 months after the surgery
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6 month
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Simple numeric scale for postoperative pain
Time Frame: 2 days
|
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
Time Frame: 10 days
|
Amount of opioids used during hospitalization
|
10 days
|
Admission rate in Intensive care unit
Time Frame: 3 month
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Rate of patients admitted in intensive care unit after surgery
|
3 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: GABEREL Thomas, MCU
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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