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

Depression Clinical Trial

— ESPOD-BI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303325
• Other study ID #: 20200225
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-asberg Depression Rating Scale score	Changes of Montgomery-asberg Depression Rating Scale score	from baseline to postoperative 24 hours
Secondary	Bispectral index	Changes of bispectral index data	from 8pm to 6am on the first postoperative night
Secondary	Gut microbiota	changs of gut microbiota	from baseline to postoperative 72 hours