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

• Status: Not yet recruiting
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University, China
• Treatments: Anesthetics; Esketamine

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