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

Sponsor

China Medical University, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT04303325

Collaborator

(none)

Enrollment

Location

Arms

14.7

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Esketamine Drug: Saline Solution	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 8, 2021

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Montgomery-asberg Depression Rating Scale score [from baseline to postoperative 24 hours]
Changes of Montgomery-asberg Depression Rating Scale score

Secondary Outcome Measures

Bispectral index [from 8pm to 6am on the first postoperative night]
Changes of bispectral index data
Gut microbiota [from baseline to postoperative 72 hours]
changs of gut microbiota

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Hospital of China Medical University	Shenyang	Liaoning	China	110001

Sponsors and Collaborators

China Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wen-fei Tan, Professor, China Medical University, China

ClinicalTrials.gov Identifier:

NCT04303325

Other Study ID Numbers:

20200225

First Posted:

Mar 11, 2020

Last Update Posted:

Nov 12, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wen-fei Tan, Professor, China Medical University, China

Additional relevant MeSH terms:

Depression

Depressive Disorder

Esketamine

Study Results

No Results Posted as of Nov 12, 2021