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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Brain Tumor, Supratentorial,Outcome
• Intervention / Treatment: Other: Bispectral index will be targeted at 35; Other: Bispectral index will be targeted at 50

• Study Type: Interventional
• Enrollment (Actual): 1461
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tian Tan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; Beijing Sanbo Brain Hospital; Zhejiang University; The Affiliated Hospital of Inner Mongolia Medical University; Anhui Provincial Hospital; Guangdong 999 Brain Hospital; Shanxi Provincial People's Hospital; Guiyang Jinyang Hospital
• Investigators: Study Chair: Ruquan Han, M.D., Ph.D, Department of Anesthesiology, Beijing Tian Tan Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): November 4, 2019
• Study Completion (Actual): November 4, 2019

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 29, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Supratentorial Neoplasms
• Other Study ID Numbers: 2016-1-20410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No