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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

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date November 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
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 reduction in the WHODAS score.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
Official Title  ICMJE Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Anesthesia, Brain Tumor, Supratentorial,Outcome
Intervention  ICMJE
  • Other: Bispectral index will be targeted at 50
    The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
  • Other: Bispectral index will be targeted at 35
    The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
Study Arms  ICMJE
  • The deep anesthesia group
    Intervention: Other: Bispectral index will be targeted at 35
  • The light anesthesia group
    Intervention: Other: Bispectral index will be targeted at 50
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2020)
1461
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
3800
Actual Study Completion Date  ICMJE November 4, 2019
Actual Primary Completion Date November 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033693
Other Study ID Numbers  ICMJE 2016-1-20410
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yuming Peng, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE
  • 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  ICMJE
Study Chair: Ruquan Han, M.D., Ph.D Department of Anesthesiology, Beijing Tian Tan Hospital
PRS Account Beijing Tiantan Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP