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

China Medical University, China

Status and phase: Enrolling; Phase 4

Conditions: Depression

Treatments: Drug: Saline Solution; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04303325

20200225

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline Solution

Esketamine

Active Comparator group

Description:

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

Treatment:

Drug: Esketamine