the First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Location status: Recruiting
NCT Number: NCT04303325
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Phase 4
Shenyang, Liaoning, 110001, China
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Time frame: from baseline to postoperative 24 hours
Changes of Montgomery-asberg Depression Rating Scale score
Time frame: from 8pm to 6am on the first postoperative night
Changes of bispectral index data
Time frame: from baseline to postoperative 72 hours
changs of gut microbiota
China Medical University, China
Other
Acronym: ESPOD-BI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06638606
Anxiety, Anxiety Disorders
Tehran, Iran
View Trial DetailsNCT06644573
Alzheimer Disease, Alzheimer Disease or Associated Disorder
Aventura, Florida, United States
View Trial DetailsNCT03129204
Anxiety, Anxiety Disorders
Tampa, Florida, United States
View Trial DetailsNCT03673397
Behavior, Behavioral Symptoms
Sankt Gallen, Switzerland
View Trial Details