Back to resultsStudy of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor (DEPTH)
Primary Purpose
Anesthesia, Brain Tumor, Supratentorial,Outcome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bispectral index will be targeted at 50
Bispectral index will be targeted at 35
Sponsored by
About this trial
This is an interventional other trial for Anesthesia, Brain Tumor, Supratentorial,Outcome
Eligibility Criteria
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.
Sites / Locations
- Beijing Tian Tan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
The deep anesthesia group
The light anesthesia group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03033693
First Posted
January 24, 2017
Last Updated
December 29, 2021
Sponsor
Beijing Tiantan Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT03033693
Brief Title
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Acronym
DEPTH
Official Title
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Brain Tumor, Supratentorial,Outcome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The deep anesthesia group
Arm Type
Other
Arm Title
The light anesthesia group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Bispectral index will be targeted at 50
Intervention Description
The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
Intervention Type
Other
Intervention Name(s)
Bispectral index will be targeted at 35
Intervention Description
The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
Primary Outcome Measure Information:
Title
Disability-free survival rate
Description
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.
Time Frame
Postoperative 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Organizational Affiliation
Department of Anesthesiology, Beijing Tian Tan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tian Tan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28899891
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
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