Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor (DEPTH)
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|ClinicalTrials.gov Identifier: NCT03033693|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : June 2, 2020
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|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.
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
|Beijing Tian Tan Hospital|
|Beijing, China, 100070|
|Study Chair:||Ruquan Han, M.D., Ph.D||Department of Anesthesiology, Beijing Tian Tan Hospital|