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

NCT04303325 | Recruiting Phase 4 DMC

• 1 other identifier: 20200225
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

depression; sleep deprivation; gut microbiota; bispectral index

Outcome Measures

Primary Outcomes (1)

• Montgomery-asberg Depression Rating Scale score

  Changes of Montgomery-asberg Depression Rating Scale score

  from baseline to postoperative 24 hours

Secondary Outcomes (2)

• Bispectral index

  from 8pm to 6am on the first postoperative night

• Gut microbiota

  from baseline to postoperative 72 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Saline Solution

Esketamine

ACTIVE COMPARATOR

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

Drug: Esketamine

Interventions

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.

Esketamine

Saline Solution DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Depression; Sleep Deprivation

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 11, 2020
• Study Start: October 8, 2021
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)