Clinical trial

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

Aliases

20200225, NCT04303325

Name

20200225

Description

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.

Trial arms

Trial start

2021-10-08

Estimated PCD

2024-10-30

Trial end

2024-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Esketamine

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

Arms:

Esketamine

Saline Solution

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

Arms:

Control

Size

Primary endpoint

Montgomery-asberg Depression Rating Scale score

from baseline to postoperative 24 hours

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}

Updated at

2024-07-22

1 organization

Organization

China Medical University