Actively Recruiting

Phase 4
Age: 18Years - 65Years
FEMALE
NCT04303325

Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

Led by China Medical University, China · Updated on 2024-07-22

72

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.

CONDITIONS

Official Title

Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients at least 18 years old and pre-menopausal
  • Scheduled for elective breast cancer surgery
  • Classified as American Society of Anaesthesiologists (ASA) risk I or II
  • Montgomery-Asberg Depression Rating Scale (MADRS) score of 22 or higher
Not Eligible

You will not qualify if you...

  • Cognitive difficulties
  • Partial or complete removal of the stomach (gastrectomy)
  • Previous surgery on the esophagus
  • Unable to follow the study requirements
  • Currently participating in another study or participated within the last month

AI-Screening

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Trial Site Locations

Total: 1 location

1

the First Hospital of China Medical University

Shenyang, Liaoning, China, 110001

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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