Anesthesia, Brain Tumor, Supratentorial,Outcome
Conditions
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.
Interventions
OTHERBispectral index will be targeted at 50
The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
OTHERBispectral index will be targeted at 35
The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
Sponsors
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
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability-free survival rate | 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. |
Countries
China
Outcome results
None listed