Chronic Subdural HematomaNCT03666949
General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma
A study testing All General anesthesia and All Locoregional anesthesia in people with Chronic Subdural Hematoma, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- All General anesthesia and All Locoregional anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subdural chronic hematoma uni or bilateral
- Obtaining an oral consent
- french speaker
- affilliation to French social security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Remi Hestin
Caen, Calvados, 14000
Rémi HESTIN, 00330648729375, remitiopo@hotmail.com
remi hestin, 0648729375, remitiopo@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- All General anesthesia, All Locoregional anesthesia
- Keywords
- chronic subdural hematoma, general anesthesia, locoregional anesthesia, length of stay
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All General anesthesiaDrug
Also called GA
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 anesthesiaDrug
Also called ALR
Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: All General anesthesia |
| All Locoregional anesthesia | Other | Use of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block Receives: Drug: All Locoregional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative theoretical length of stay
Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist
Measured: 10 days
Secondary outcomes (9)
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)
Measured: 3 month
Rates of postoperative surgical complications
acute subdural hematoma; surgical site infection; hydrocephalus
Measured: 10 days
Postoperative medical complications rate
infectious pneumonia, urinary tract infection, phlebitis, pulmonary embolism, other
Measured: 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)
Measured: 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.
Measured: 2 days
Mortality rate at 6 months.
Rate of patients died 6 months after the surgery
Measured: 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.
Measured: 2 days
Opioid consumption
Amount of opioids used during hospitalization
Measured: 10 days
Admission rate in Intensive care unit
Rate of patients admitted in intensive care unit after surgery
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 May 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GABEREL Thomas, Principal investigator, MCU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666949
- Sponsor's protocol ID
- NEURANESTH
- Status last verified
- May 2018
- First submitted
- 12 Jun 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03666949
- Acronym / sponsor ID
- NEURANESTH
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, general anesthesia, locoregional anesthesia, length of stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All General anesthesia | Other | Drug: All General anesthesiaUse 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 | Other | Drug: All Locoregional anesthesiaUse of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subdural chronic hematoma uni or bilateral
- Obtaining an oral consent
- french speaker
- affilliation to French social security
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All General anesthesiaAlso: GAUse 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 anesthesiaAlso: ALRUse of a local anesthetic(" xylocaine 1%") for the realization of scalp nerve block | Drug | All Locoregional anesthesia |
Primary outcome
postoperative theoretical length of stay
Time frame: 10 days
Theoretical duration of postoperative hospitalization: discharge authorized after medical checklist
9 secondary outcomes
Modified Rankin score (0-6)
Time frame: 3 month
Rates of postoperative surgical complications
Time frame: 10 days
Postoperative medical complications rate
Time frame: 10 days
LIKERT scale: a measure of the degree of satisfaction of the surgeon and the patient.
Time frame: baseline
MINI COG: Measurement of postoperative cognitive impairment at 6 months
Time frame: 2 days
Mortality rate at 6 months.
Time frame: 6 month
Simple numeric scale for postoperative pain
Time frame: 2 days
Opioid consumption
Time frame: 10 days
Admission rate in Intensive care unit
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GABEREL Thomas principal investigator
MCU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All General anesthesia and All Locoregional anesthesia in people with Chronic Subdural Hematoma, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HESTIN Remi (0033648729375, remitiopo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative theoretical length of stay (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.