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

This prospective, randomized, double-blinded trial (n=36) will investigate the effect of esketamine on postoperative depression, gut microbiota, and bispectral index data in depression patients undergoing breast cancer operation.

Breast cancer patients who have a high risk of developing depression (20%-45%) will be randomly assigned to receive either esketamine or saline as an adjunct to general anaesthesia during their operation. Esketamine, increasingly used in treating resistant depression, will be assessed for its efficacy in alleviating postoperative depression in this population.

The study aims to evaluate changes in postoperative depression, gut microbiota, and bispectral index data between the two groups. The primary outcome measure will be the change in Montgomery-asberg Depression Rating Scale score from baseline to postoperative 24 hours. Secondary outcome measures include changes in bispectral index data from 8 pm to 6 am on the first postoperative night and changes in gut microbiota from baseline to postoperative 72 hours.

Eligible participants must be female, aged 18 to 65 years, pre-menopausal, scheduled for elective breast cancer operation, and have an American Society of Anaesthesiologists (ASA) risk classification I-II. Exclusion criteria include cognitive difficulties, previous esophageal surgery, and ongoing participation in another study within the past month.

This interventional trial, conducted by China Medical University in Liaoning, China, commenced on October 8, 2021, and is expected to conclude on October 30, 2023. The study is phase IV and follows a parallel assignment design with quadruple masking (participant, care provider, investigator, outcomes assessor).

Topic Depression
Compound Ketamine Placebo
Country China
Visit trial
Status Recruiting
Results Published No
Start date 08 October 2021
End date 30 December 2023
Phase Phase IV
Design Blinded
Type Interventional
Generation Second
Participants 36
Sex Female
Age 18- 65
Therapy No

Trial Details

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.

NCT Number NCT04303325

Data attribution

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