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NCT Number: NCT04303325

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

Location contact

Wen-fei Tan, M.D.,Ph.D

CONTACT

[email protected]

024-83283100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Montgomery-asberg Depression Rating Scale score

    Time frame: from baseline to postoperative 24 hours

    Changes of Montgomery-asberg Depression Rating Scale score

Secondary outcomes

  1. Bispectral index

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

    Changes of bispectral index data

  2. Gut microbiota

    Time frame: from baseline to postoperative 72 hours

    changs of gut microbiota

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Acronym: ESPOD-BI

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2020
Registry last updated
Jul 22, 2024

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.

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