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

January 15, 2023 updated by: Wenfei Tan, China Medical University, China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.

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

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Drug: Saline Solution
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Active Comparator: Esketamine
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-asberg Depression Rating Scale score
Time Frame: from baseline to postoperative 24 hours
Changes of Montgomery-asberg Depression Rating Scale score
from baseline to postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bispectral index
Time Frame: from 8pm to 6am on the first postoperative night
Changes of bispectral index data
from 8pm to 6am on the first postoperative night
Gut microbiota
Time Frame: from baseline to postoperative 72 hours
changs of gut microbiota
from baseline to postoperative 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Anticipated)

October 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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