Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer

University of Chinese Academy Sciences

Status: Enrolling

Conditions: Depressive Symptom; Cytoreductive Surgery; Ovarian Cancer

Treatments: Drug: placebo; Drug: esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06624878

IRB-2024-885 (IIT)

Details and patient eligibility

About

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.

Enrollment: 568 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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568 participants in 2 patient groups, including a placebo group

the esketamine group

Experimental group

Treatment:

Drug: esketamine

the placebo group

Placebo Comparator group

Treatment:

Drug: placebo