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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03033693
Collaborator
Shanxi Provincial People's Hospital (Other), Guiyang Jinyang Hospital (Other), Beijing Sanbo Brain Hospital (Other), The Second Hospital of Hebei Medical University (Other), The Affiliated Hospital of Inner Mongolia Medical University (Other), Chinese PLA General Hospital (Other), Anhui Provincial Hospital (Other), Guangdong 999 Brain Hospital (Other), Zhejiang University (Other)
1,461
Enrollment
1
Location
2
Arms
33.1
Actual Duration (Months)
44.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bispectral index will be targeted at 50
  • Other: Bispectral index will be targeted at 35
 N/A

Study Design

Study Type:
Interventional
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 :
Feb 1, 2017
Actual Primary Completion Date :
Nov 4, 2019
Actual Study Completion Date :
Nov 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: 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.
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tian Tan Hospital Beijing China 100070

Sponsors and Collaborators

  • Beijing Tiantan Hospital
  • 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

Investigators

  • Study Chair: Ruquan Han, M.D., Ph.D, Department of Anesthesiology, Beijing Tian Tan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT03033693
Other Study ID Numbers:
  • 2016-1-20410
First Posted:
Jan 27, 2017
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Supratentorial Neoplasms

Study Results

No Results Posted as of Jan 14, 2022