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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033693
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
Shaanxi 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
Information provided by (Responsible Party):
Yuming Peng, Beijing Tiantan Hospital

Study Description
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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
Anesthesia, Brain Tumor, Supratentorial,Outcome Other: Bispectral index will be targeted at 50 Other: Bispectral index will be targeted at 35 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2017
Actual Primary Completion Date : November 4, 2019
Actual Study Completion Date : November 4, 2019
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China
Beijing Tian Tan Hospital
Beijing, China, 100070
Sponsors and Collaborators
Beijing Tiantan Hospital
Shaanxi 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
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Study Chair: Ruquan Han, M.D., Ph.D Department of Anesthesiology, Beijing Tian Tan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yuming Peng, Associate professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03033693    
Other Study ID Numbers: 2016-1-20410
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases