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

NCT03033693 | Completed DMC

• 1 other identifier: 2016-1-20410
• Study Type: interventional
• Target: 1,461
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Brain Tumor, Supratentorial,Outcome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

The deep anesthesia group

OTHER

Other: Bispectral index will be targeted at 35

The light anesthesia group

OTHER

Other: Bispectral index will be targeted at 50

Interventions

Bispectral index will be targeted at 50 OTHER

The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.

The light anesthesia group

Bispectral index will be targeted at 35 OTHER

The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.

The deep anesthesia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Shanxi Provincial People's Hospital: collaborator
• Guiyang Jinyang Hospital: collaborator
• Beijing Sanbo Brain Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Chinese PLA General Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Guangdong 999 Brain Hospital: collaborator
• Zhejiang University: collaborator

Study Sites (1)

Beijing Tian Tan Hospital

Beijing, 100070, China

Location

Related Publications (1)

• 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.

  PMID: 28899891 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ruquan Han, M.D., Ph.D

  Department of Anesthesiology, Beijing Tian Tan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 27, 2017
• Study Start: February 1, 2017
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

CN (1)