Anesthesia, Brain Tumor, Supratentorial,OutcomeDEPTHNCT03033693
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
A study testing Bispectral index will be targeted at 50 and Bispectral index will be targeted at 35 in people with Anesthesia, Brain Tumor, Supratentorial,Outcome, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Brain Tumor, Supratentorial,Outcome
- What is being tested?
- Bispectral index will be targeted at 50 and Bispectral index will be targeted at 35
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,461 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 4 Nov 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to receive elective supratentorial tumor resection under general anesthesia from 2017 to 2019 will be recruited in the trial. Inclusion criteria include ages between 18 and 80 years old, American Society of Anesthesiologists (ASA) physical status Ⅲ-Ⅳ, surgery duration expected to be equal or more than three hours, postoperative hospital stay expected to be equal or more than five nights, and monitoring BIS throughout anesthesia.
Who cannot join
- Patients who undergo emergency or awake craniotomy surgery, or unable to present the written consent will be excluded from the trial. The patients whose incision site conflicts with the placement of BIS electrode on the frontal and temporal lobe will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The investigators are performing a randomized and parallel group trial. The aim of the study is to determine whether there is a causal relationship between the depth of anesthesia and postoperative clinical outcome in patients undergoing supratentorial tumor surgery.
- Being tested
- Bispectral index will be targeted at 50, Bispectral index will be targeted at 35
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index will be targeted at 50Other
The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
Bispectral index will be targeted at 35Other
The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
| Study group | Role | What they receive |
|---|---|---|
| The deep anesthesia group | Other | Not described Receives: Other: Bispectral index will be targeted at 35 |
| The light anesthesia group | Other | Not described Receives: Other: Bispectral index will be targeted at 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability-free survival rate
World Health Organization Disability Assessment Schedule 2.0 Scale will be used to assess the body disability. Disability is defined as a 4-point increasement in the WHODAS score.
Measured: Postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, Brain Tumor, Supratentorial,OutcomeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, Guiyang Jinyang Hospital, Beijing Sanbo Brain Hospital, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Chinese PLA General Hospital, Anhui Provincial Hospital, Guangdong 999 Brain Hospital, Zhejiang University
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph.D, Study chair, Department of Anesthesiology, Beijing Tian Tan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033693
- Sponsor's protocol ID
- 2016-1-20410
- Acronym
- DEPTH
- Status last verified
- Dec 2021
- First submitted
- 24 Jan 2017
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui Q, Peng Y, Liu X, Jia B, Dong J, Han R. Effect of anesthesia depth on postoperative clinical outcome in patients with supratentorial tumor (DEPTH): study protocol for a randomized controlled trial. BMJ Open. 2017 Sep 11;7(9):e016521. doi: 10.1136/bmjopen-2017-016521.
PubMed 28899891
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
- ClinicalTrials.gov ID
- NCT03033693
- Acronym / sponsor ID
- DEPTH / 2016-1-20410
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,461 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, Guiyang Jinyang Hospital, Beijing Sanbo Brain Hospital, The Second Hospital of Hebei Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Chinese PLA General Hospital, Anhui Provincial Hospital, Guangdong 999 Brain Hospital, Zhejiang University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 27 Jan 2017 (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.
Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The investigators are performing a randomized and parallel group trial. The aim of the study is to determine whether there is a causal relationship between the depth of anesthesia and postoperative clinical outcome in patients undergoing supratentorial tumor surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The deep anesthesia group | Other | Other: Bispectral index will be targeted at 35 |
| The light anesthesia group | Other | Other: Bispectral index will be targeted at 50 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to receive elective supratentorial tumor resection under general anesthesia from 2017 to 2019 will be recruited in the trial. Inclusion criteria include ages between 18 and 80 years old, American Society of Anesthesiologists (ASA) physical status Ⅲ-Ⅳ, surgery duration expected to be equal or more than three hours, postoperative hospital stay expected to be equal or more than five nights, and monitoring BIS throughout anesthesia.
Key exclusion criteria (1 listed)
- Patients who undergo emergency or awake craniotomy surgery, or unable to present the written consent will be excluded from the trial. The patients whose incision site conflicts with the placement of BIS electrode on the frontal and temporal lobe will also be excluded from the study.
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 |
|---|---|---|
| Bispectral index will be targeted at 50The depth of general anesthesia will be monitored by bispectral index (BIS) at 50. | Other | The light anesthesia group |
| Bispectral index will be targeted at 35The depth of general anesthesia will be monitored by bispectral index (BIS) at 35. | Other | The deep anesthesia group |
Primary outcome
Disability-free survival rate
Time frame: Postoperative 30 days
World Health Organization Disability Assessment Schedule 2.0 Scale will be used to assess the body disability. Disability is defined as a 4-point increasement in the WHODAS score.
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 14 Jan 2022.
- Derived from this study: PubMed 28899891Cui Q, Peng Y, Liu X, Jia B, Dong J, Han R. Effect of anesthesia depth on postoperative clinical outcome in patients with supratentorial tumor (DEPTH): study protocol for a randomized controlled trial. BMJ Open. 2017 Sep 11;7(9):e016521. doi: 10.1136/bmjopen-2017-016521.
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.
Ruquan Han, M.D., Ph.D study chair
Department of Anesthesiology, Beijing Tian Tan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index will be targeted at 50 and Bispectral index will be targeted at 35 in people with Anesthesia, Brain Tumor, Supratentorial,Outcome, run by Beijing Tiantan Hospital at 1 site in China.
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 1 inclusion and 1 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 14 Jan 2022. 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 China. 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?
Disability-free survival rate (time frame: Postoperative 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03033693, which also lists 1 linked publication.
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 14 Jan 2022; AzTrials last refreshed its copy on 26 Oct 2026.