Adult Brain TumorPhase 4NCT02193568
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy
A Phase 4 study testing Arm I (light sedation) and Arm II (intubated general anesthesia) in people with Adult Brain Tumor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adult Brain Tumor
- What is being tested?
- Arm I (light sedation) and Arm II (intubated general anesthesia)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2014to 24 Jan 2019
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant females
- Elective craniotomy for supratentorial brain tumors
- Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)
- First craniotomy
- American Society of Anesthesiologists (ASA) I-III
- Body mass index (BMI) < 35
Who cannot join
- Posterior fossa tumor/approach for tumor resection requiring the prone position
- Traumatic lesions/hematomas
- Emergency case
- Systemic disease burden with metastatic tumor to the brain
- Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay
- Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.
SECONDARY OBJECTIVES:
- To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.
- To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive light sedation (awake) and undergo craniotomy.
ARM II: Patients receive intubated general anesthesia and undergo craniotomy.
After completion of study, patients are followed up at 1month and 1 year.
- Conditions
- Adult Brain Tumor
- Being tested
- Arm I (light sedation), Arm II (intubated general anesthesia)
- Keywords
- Supratentorial Glioma, Craniotomy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (light sedation)Procedure or surgery
Also called anesthesia
If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.
Arm II (intubated general anesthesia)Procedure or surgery
Also called general anesthesia
Receive intubated general anesthesia
Arm II (intubated general anesthesia)Procedure or surgery
Also called therapeutic conventional surgery
Undergo craniotomy
Arm II (intubated general anesthesia)Other
Also called questionnaire administration
Ancillary studies
Arm I (light sedation)Procedure or surgery
Also called therapeutic conventional surgery
Undergo craniotomy
Arm I (light sedation)Other
Also called questionnaire administration
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (light sedation) | Experimental | Patients receive light sedation (awake) and undergo craniotomy. Receives: Procedure: Arm I (light sedation); Procedure: Arm II (intubated general anesthesia); Other: Arm II (intubated general anesthesia); Other: Arm I (light sedation) |
| Arm II (intubated general anesthesia) | Active comparator | Patients receive intubated general anesthesia and undergo craniotomy. Receives: Procedure: Arm II (intubated general anesthesia); Other: Arm II (intubated general anesthesia); Procedure: Arm I (light sedation); Other: Arm I (light sedation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare overall hospital length of stay for patients in each of 2 arms
Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.
Measured: Up to 1 year
Secondary outcomes (5)
Compare resource utilization between two groups
Compare costs of hospital stay, anesthesia, and surgery
Measured: Up to 1 year
Assess the frequency of post-operative delirium
Post-operative delirium will be assessed using the Memorial Delirium Assessment Scale (MDAS); a tool developed to measure the severity of delirium and reflects the main diagnostic criteria and symptoms of delirium. The MDAS is structured as a ten-item, four-point clinician-rated scale (possible range, 0-30) designed to quantify the severity of delirium in medically ill patients. A score of 13 has been recommended by the original authors as a cutoff for establishing the diagnosis of delirium.
Measured: Up to 1 year
Measure patient perceptions
Will be measured by asking patients about their overall positive experiences, if they understood rationale behind non-intubated craniotomy; necessary to improve outcomes and minimize complications; self-protection/preservation, if they appreciated receiving information before surgery to help them make informed decisions, and their trust in the surgeon via survey to be conducted at the conclusion of the inpatient stay, before hospital discharge
Measured: Up to 1 year
Track patient complications during hospital stay
Track patient nausea/vomiting, pain, hematology/lab stability, hemodynamic stability
Measured: Up to 1 year
Track re-admission and extended hospital stay rates
Tracking will be done using the EMR and follow-up calls
Measured: Up to 1 year from the date of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start30 Apr 2014
- Primary completion8 Oct 2016
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Brain TumorStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Elder, Ohio State University Comprehensive Cancer Center
- Investigators
- James Elder, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193568
- Sponsor's protocol ID
- OSU-12161
- Other IDs
- NCI-2014-01110
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Blinded, Randomized Study of Awake vs Intubated General Anesthesia in Patients Undergoing Elective Craniotomy for Supratentorial Glioma Resection
- ClinicalTrials.gov ID
- NCT02193568
- Acronym / sponsor ID
- OSU-12161
- Conditions
- Adult Brain Tumor
- Keywords
- Supratentorial Glioma, Craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Apr 2014
- Primary completion
- 8 Oct 2016 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 17 Jul 2014 (estimated)
- 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 randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.
Detailed description
PRIMARY OBJECTIVES:
- To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.
SECONDARY OBJECTIVES:
- To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.
- To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive light sedation (awake) and undergo craniotomy.
ARM II: Patients receive intubated general anesthesia and undergo craniotomy.
After completion of study, patients are followed up at 1month and 1 year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (light sedation) | Experimental | Procedure: Arm I (light sedation), Procedure: Arm II (intubated general anesthesia), Other: Arm II (intubated general anesthesia), Other: Arm I (light sedation)Patients receive light sedation (awake) and undergo craniotomy. |
| Arm II (intubated general anesthesia) | Active comparator | Procedure: Arm II (intubated general anesthesia), Other: Arm II (intubated general anesthesia), Procedure: Arm I (light sedation), Other: Arm I (light sedation)Patients receive intubated general anesthesia and undergo craniotomy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-pregnant females
- Elective craniotomy for supratentorial brain tumors
- Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)
- First craniotomy
- American Society of Anesthesiologists (ASA) I-III
Key exclusion criteria (8 listed)
- Posterior fossa tumor/approach for tumor resection requiring the prone position
- Traumatic lesions/hematomas
- Emergency case
- Systemic disease burden with metastatic tumor to the brain
- Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay
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 |
|---|---|---|
| Arm I (light sedation)Also: anesthesiaIf patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation. | Procedure or surgery | Arm I (light sedation) |
| Arm II (intubated general anesthesia)Also: general anesthesiaReceive intubated general anesthesia | Procedure or surgery | Arm II (intubated general anesthesia) |
| Arm II (intubated general anesthesia)Also: therapeutic conventional surgeryUndergo craniotomy | Procedure or surgery | Arm I (light sedation), Arm II (intubated general anesthesia) |
| Arm II (intubated general anesthesia)Also: questionnaire administrationAncillary studies | Other | Arm I (light sedation), Arm II (intubated general anesthesia) |
| Arm I (light sedation)Also: therapeutic conventional surgeryUndergo craniotomy | Procedure or surgery | Arm I (light sedation), Arm II (intubated general anesthesia) |
| Arm I (light sedation)Also: questionnaire administrationAncillary studies | Other | Arm I (light sedation), Arm II (intubated general anesthesia) |
Primary outcome
Compare overall hospital length of stay for patients in each of 2 arms
Time frame: Up to 1 year
Will be summarized for each arm and compared between light sedation and general anesthesia arm using two-sample test. Regression model will also be used to study the association between the length of stay and the type of anesthesia with potential confounder variables.
5 secondary outcomes
Compare resource utilization between two groups
Time frame: Up to 1 year
Assess the frequency of post-operative delirium
Time frame: Up to 1 year
Measure patient perceptions
Time frame: Up to 1 year
Track patient complications during hospital stay
Time frame: Up to 1 year
Track re-admission and extended hospital stay rates
Time frame: Up to 1 year from the date of surgery
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 13 Mar 2019.
- The JameslineLink provided by the sponsor.
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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.
James Elder, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arm I (light sedation) and Arm II (intubated general anesthesia) in people with Adult Brain Tumor, run by Ohio State University Comprehensive Cancer Center 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 13 Mar 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Compare overall hospital length of stay for patients in each of 2 arms (time frame: Up to 1 year). 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 13 Mar 2019.