NCT04303325

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-08
• Primary completion: 2024-10-30
• Completion: 2024-12-30
• First posted: 2020-03-11
• Last updated: 2024-07-22

Locations

1 site across 1 country: China