Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery

NCT ID: NCT05155969

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-15

Brief Summary

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Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.

Detailed Description

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Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression.

In patients undergoing cardiac surgery, postoperative depressive symptoms are common.

This study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.

Conditions

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Postoperative Depression

Keywords

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esketamine postoperative depression cardic surgey

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eskatamine group

Low-dose esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction

Placebo group

Placebo (40 ml normal saline) is intravenously infused in 40 minutes before anesthesia induction.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes.

Interventions

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Esketamine

esketamine (0.3 mg/kg in 100 ml normal saline) is intravenously infused 40 minutes before anesthesia induction

Intervention Type DRUG

Normal saline

Normal saline will be administrated intravenously at the dural opening, with a total dose of 0.5 ml/kg and continual infusion for 40 minutes.

Intervention Type DRUG

Other Intervention Names

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Ketamine hydrochloride saline

Eligibility Criteria

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Inclusion Criteria

* 1:Patients scheduled for heart surgery
* 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors
* 3:Over 18 years of age
* 4:American Society of Anesthesiologists physical status I-III

Exclusion Criteria

* 1:History of epilepsy
* 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks
* 3: Psychiatric illness
* 4: Drug abuse
* 5:History of allergy to esketamine
* 6:Hyperthyroidism
* 7:Patients can not cooperate with investigators on psychiatric assessments
* 8:Pregnant or breastfeeding woman
* 9:refuse to sign informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anshi Wu

OTHER

Sponsor Role lead

Responsible Party

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Anshi Wu

Head of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anshi Wu Wu, Ph.D

Role: STUDY_CHAIR

Beijing Chao-Yang Hospital, Capital Medical Unive

Locations

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Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Anshi Wu Wu, Ph.D

Role: CONTACT

Phone: +861085351330

Email: [email protected]

Facility Contacts

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Anshi Wu, MD

Role: primary

Anshi Wu, Ph.D

Role: primary

Other Identifiers

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10110815

Identifier Type: -

Identifier Source: org_study_id