Intracranial GliomaNCT03621748
Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
A study testing Awake Anesthesia Protocol and Non-awake Anesthesia Protocol in people with Intracranial Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Glioma
- What is being tested?
- Awake Anesthesia Protocol and Non-awake Anesthesia Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 21 May 2023
- 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
- Patients with age ≥18 years old.
- WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
- An elective procedure.
- A single lesion.
- No major comorbidities that would necessitate an extended hospital stay.
- Newly diagnosed tumors.
Who cannot join
- Patients with age < 18 years old.
- Non-gliomas
- Eloquent location (motor, sensory, language)
- Non-elective procedure.
- Multiple lesions.
- Major comorbidities.
- Recurrent tumors.
- Patients lacking capacity to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
This study protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
Read the detailed description
This is a single-center, prospective randomized open or non-blinded end-point (PROBE) clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. The experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.
- Conditions
- Intracranial Glioma
- Being tested
- Awake Anesthesia Protocol, Non-awake Anesthesia Protocol
- Keywords
- craniotomy, awake craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake Anesthesia ProtocolProcedure or surgery
Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
Non-awake Anesthesia ProtocolProcedure or surgery
Non-awake is general anesthesia as per convention with intubation.
| Study group | Role | What they receive |
|---|---|---|
| Non-Awake Cohort | Active comparator | Cohort undergoing craniotomy utilizing general anesthesia protocol Receives: Procedure: Non-awake Anesthesia Protocol |
| Awake Cohort | Experimental | Cohort undergoing craniotomy utilizing awake anesthesia protocol Receives: Procedure: Awake Anesthesia Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of resection
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
Measured: up to 48 hrs post operation
Secondary outcomes (3)
Percentage of baseline tumor volume resected
Measured by MRI
Measured: up to 48 hrs post operation
VAS Postoperative anxiety
Postoperative Anxiety scale measured using a 0 to 10 visual analog scale (0: no anxiety, 10: worst anxiety)
Measured: Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Length of Surgery
defined as time entering OR and leaving OR
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jun 2019
- Primary completion21 May 2023
- Study completion21 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial GliomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaisorn L. Chaichana, Mayo Clinic
- Investigators
- Kaisorn L Chaichana, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621748
- Sponsor's protocol ID
- 18-005248
- Status last verified
- May 2023
- First submitted
- 2 Aug 2018
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial for Awake vs. Asleep Craniotomy for Non-eloquent Gliomas
- ClinicalTrials.gov ID
- NCT03621748
- Acronym / sponsor ID
- 18-005248
- Conditions
- Intracranial Glioma
- Keywords
- craniotomy, awake craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 8 Aug 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 protocol examines a comparison between local and general anesthesia (Awake vs. Asleep Craniotomy) in the removal of brain tumors that are in areas of the brain that do not directly control bodily functions (non-eloquent gliomas).
Detailed description
This is a single-center, prospective randomized open or non-blinded end-point (PROBE) clinical trial. Patients will be selected by the neurosurgeon according to the inclusion and exclusion criteria. Patients who consent to randomization will have confirmed non-eloquent status confirmed by independent surgeon and will be randomized into 1 of 2 treatment groups utilizing a dynamic minimization approach. The experimental group with randomization of patients who will undergo awake craniotomy for both high and low grade gliomas in non-eloquent areas or a control group of patients who will have asleep craniotomy for both high and low grade gliomas in non-eloquent regions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Awake Cohort | Active comparator | Procedure: Non-awake Anesthesia ProtocolCohort undergoing craniotomy utilizing general anesthesia protocol |
| Awake Cohort | Experimental | Procedure: Awake Anesthesia ProtocolCohort undergoing craniotomy utilizing awake anesthesia protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with age ≥18 years old.
- WHO grade I, II, III, and IV Glioma in non-eloquent brain cortex based on magnetic resonance imaging (MRI)
- An elective procedure.
- A single lesion.
- No major comorbidities that would necessitate an extended hospital stay.
Key exclusion criteria (8 listed)
- Patients with age < 18 years old.
- Non-gliomas
- Eloquent location (motor, sensory, language)
- Non-elective procedure.
- Multiple lesions.
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 |
|---|---|---|
| Awake Anesthesia ProtocolAwake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure. | Procedure or surgery | Awake Cohort |
| Non-awake Anesthesia ProtocolNon-awake is general anesthesia as per convention with intubation. | Procedure or surgery | Non-Awake Cohort |
Primary outcome
Extent of resection
Time frame: up to 48 hrs post operation
Extent of resection (EOR) defined as the residual volume, in cm3, of tumor measured by MRI
3 secondary outcomes
Percentage of baseline tumor volume resected
Time frame: up to 48 hrs post operation
VAS Postoperative anxiety
Time frame: Day 1(+14 days) , Post op day 0, 1, 2 weeks, 3mth
Length of Surgery
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kaisorn L Chaichana principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awake Anesthesia Protocol and Non-awake Anesthesia Protocol in people with Intracranial Glioma, run by Mayo Clinic at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 26 May 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of resection (time frame: up to 48 hrs post operation). 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 26 May 2023.