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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Esketamine

    Drug

    All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.

  • Saline Solution

    Drug

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

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: EsketamineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Montgomery-asberg Depression Rating Scale score

Changes of Montgomery-asberg Depression Rating Scale score

Time frame
from baseline to postoperative 24 hours

Secondary outcomes

1

Bispectral index

Changes of bispectral index data

Time frame
from 8pm to 6am on the first postoperative night
2

Gut microbiota

changs of gut microbiota

Time frame
from baseline to postoperative 72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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