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

ConditionDepression
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorChina Medical University, China

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Cognitive difficulties

Partial or complete gastrectomy

Previous esophageal surgery

Inability to conform to the study's requirements

Trial design

Treatments tested in this trial

  • Esketamine
  • Saline Solution

Treatment groups

72 Participants
are divided into 2 treatment groups