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

Primary Purpose

Depression

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Esketamine

Saline Solution

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, sleep deprivation, gut microbiota, bispectral index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

the First Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Esketamine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Montgomery-asberg Depression Rating Scale score

Changes of Montgomery-asberg Depression Rating Scale score

Secondary Outcome Measures

Bispectral index

Changes of bispectral index data

Gut microbiota

changs of gut microbiota

Full Information

NCT ID

NCT04303325

First Posted

March 6, 2020

Last Updated

January 15, 2023

Sponsor

China Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT04303325

Brief Title

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

Acronym

ESPOD-BI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 8, 2021 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

depression, sleep deprivation, gut microbiota, bispectral index

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Esketamine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esketamine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline Solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Montgomery-asberg Depression Rating Scale score

Description

Changes of Montgomery-asberg Depression Rating Scale score

Time Frame

from baseline to postoperative 24 hours

Secondary Outcome Measure Information:

Title

Bispectral index

Description

Changes of bispectral index data

Time Frame

from 8pm to 6am on the first postoperative night

Title

Gut microbiota

Description

changs of gut microbiota

Time Frame

from baseline to postoperative 72 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

the First Hospital of China Medical University

City

Shenyang

State/Province

Liaoning

ZIP/Postal Code

110001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen-fei Tan, M.D.,Ph.D

Phone

024-83283100

winfieldtan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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