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Unknown statusPhase 4

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

NCT04303325 · ESPOD-BI · China Medical University, China

Closed to entry
Status
Not accepting participants
Phase 4
Phase
72
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-asberg Depression Rating Scale score

    Measured over from baseline to postoperative 24 hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
FEMALE
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * At least18 years and pre-menopausal; * scheduled to undergo elective breast cancer operation; * American Society of Anaesthesiologists (ASA) risk classification I-II. * Montgomery-asberg Depression Rating Scale (MADRS) score ≥22 Exclusion Criteria: * Cognitive difficulties * Partial or complete gastrectomy * Previous esophageal surgery * Inability to conform to the study's requirements * Ongoing participation or participation in another study \<1 month ago

Where

1 study site

FacilityCityRegionCountry
the First Hospital of China Medical UniversityShenyangLiaoningChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04303325 on ClinicalTrials.gov →

Last updated in the registry 2024-07-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication