Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor (DEPTH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03033693 |
Recruitment Status :
Completed
First Posted : January 27, 2017
Last Update Posted : January 14, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anesthesia, Brain Tumor, Supratentorial,Outcome | Other: Bispectral index will be targeted at 50 Other: Bispectral index will be targeted at 35 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1461 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor |
Actual Study Start Date : | February 1, 2017 |
Actual Primary Completion Date : | November 4, 2019 |
Actual Study Completion Date : | November 4, 2019 |
Arm | Intervention/treatment |
---|---|
The deep anesthesia group |
Other: Bispectral index will be targeted at 35
The depth of general anesthesia will be monitored by bispectral index (BIS) at 35. |
The light anesthesia group |
Other: Bispectral index will be targeted at 50
The depth of general anesthesia will be monitored by bispectral index (BIS) at 50. |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033693
China | |
Beijing Tian Tan Hospital | |
Beijing, China, 100070 |
Study Chair: | Ruquan Han, M.D., Ph.D | Department of Anesthesiology, Beijing Tian Tan Hospital |
Responsible Party: | Ruquan Han, Professor, Beijing Tiantan Hospital |
ClinicalTrials.gov Identifier: | NCT03033693 |
Other Study ID Numbers: |
2016-1-20410 |
First Posted: | January 27, 2017 Key Record Dates |
Last Update Posted: | January 14, 2022 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |