|

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

RECRUITINGPhase 4Sponsored by China Medical University, China
Actively Recruiting
PhasePhase 4
SponsorChina Medical University, China
Started2021-10-08
Est. completion2024-10-30
Eligibility
Age18 Years – 65 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04303325

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.

Eligibility

Age: 18 Years – 65 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerCancerDepression

Browse More Trials

Cancer trialsBreast Cancer trialsDepression trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.