Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

NCT ID: NCT06624878

Last Updated: 2025-01-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-12-31

Brief Summary

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The goal of this clinical trial is to learn if intraoperative administration of esketamine would prevent or mitigate postoperative depressive symptoms after cytoreductive surgery in ovarian cancer. The main questions it aims to answer are:

* Whether a single low dose of esketamine administered would reduce the postoperative depressive symptoms three days after cytoreductive surgery in ovarian cancer?
* Whether a single low dose of esketamine administered would relief the postoperative sleep disturbance, postoperative recovery? Researchers will compare the esketamine to a placebo (normal saline) to see if the esketamine works to reduce the postoperative depressive symptoms.

Participants will:

* Receive either 0.2 mg/kg esketamine or placebo infused intravenously after induction of general anesthesia.
* The preoperative Patient Health Questionnaire 9 (PHQ-9) scale was used to verify the symptoms suggestive of depression.

Detailed Description

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Conditions

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Ovarian Cancer Cytoreductive Surgery Depressive Symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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the esketamine group

Group Type EXPERIMENTAL

esketamine

Intervention Type DRUG

0.2 mg/kg esketamine infused intravenously after induction of general anesthesia.

the placebo group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

a placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia.

Interventions

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esketamine

0.2 mg/kg esketamine infused intravenously after induction of general anesthesia.

Intervention Type DRUG

placebo

a placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* undergoing cytoreductive surgery for ovarian cancer under general anesthesia
* ASA physical status I-III
* Ages 18-80 years

Exclusion Criteria

* Patients taking anti-psychotic medications
* Contraindications to esketamine
* Language barrier
* Inability to provide consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gu Bin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ji Zhu, MD, PHD

Role: CONTACT

057188122146

Other Identifiers

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IRB-2024-885 (IIT)

Identifier Type: -

Identifier Source: org_study_id

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