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

Phase 4

Recruiting

• Conditions: Depression
• Interventions: Drug: Saline Solution; Drug: Esketamine

• Registration Number: NCT04303325
• Lead Sponsor: China Medical University, China

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

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Study Start: 2021-10-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22
• Primary Completion: 2024-10-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline Solution	All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Esketamine	Esketamine	All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.

Primary Outcome Measures

Name	Time	Method
Montgomery-asberg Depression Rating Scale score	from baseline to postoperative 24 hours	Changes of Montgomery-asberg Depression Rating Scale score

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China