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Completed

NCT Number: NCT03033693

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

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.

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Key information

Conditions

Anesthesia, Brain Tumor, Supratentorial,Outcome Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bispectral index will be targeted at 50

Other

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

Bispectral index will be targeted at 35

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Acronym: DEPTH

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2017
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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