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

NCT04303325 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Esketamine

All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.

DRUG

Saline Solution

All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2024-10-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04303325 on ClinicalTrials.gov