Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor

Anesthesia, Brain Tumor, Supratentorial,Outcome Clinical Trial

— DEPTH  

Official title:

Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033693
• Other study ID #: 2016-1-20410
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 4, 2019

Study information

• Verified date: December 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1461
• Est. completion date: November 4, 2019
• Est. primary completion date: November 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ?-?, 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.

Related Conditions & MeSH terms

• Anesthesia, Brain Tumor, Supratentorial,Outcome
• Supratentorial Neoplasms

Intervention

Other:
• Bispectral index will be targeted at 50
The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
• Bispectral index will be targeted at 35
The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Anhui Provincial Hospital, Beijing Sanbo Brain Hospital, Chinese PLA General Hospital, Guangdong 999 Brain Hospital, Guiyang Jinyang Hospital, Shanxi Provincial People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, The Second Hospital of Hebei Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Postoperative 30 days