Clinical trial NCT06624878: Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer
Official title: Intraoperative Esketamine for Prevention of Depressive Symptoms After Cytoreductive Surgery in Ovarian Cancer: a Controlled, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Cytoreductive Surgery
Depressive Symptom
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 568
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer
timeFrame: on postoperative day 3
Secondary outcomes:
measure: the incidence of depressive symptoms in ovarian cancer
timeFrame: Baseline (before surgery), on postoperative day 30
measure: the incidence of sleep disturbance in ovarian cancer
timeFrame: Baseline (before surgery), on postoperative day 3 and on postoperative day 30
measure: the incidence of anxiety in ovarian cancer
timeFrame: Baseline (before surgery)
measure: the postoperative recovery of ovarian cancer
timeFrame: Baseline (before surgery), on postoperative day 3
measure: postoperative pain score at rest and coughing pain
timeFrame: at 1, 24, 48, 72 hours after surgery
measure: the lengh of postoperative ICU admission
timeFrame: through study completion, an average of 1-5 days
measure: the time to initiation of postoperative chemotherapy
timeFrame: through study completion, an average of 5-20 days
measure: the postoperative complications of ovarian cancer
timeFrame: within 30 days after surgery
measure: the time to walk after surgery
timeFrame: through study completion, an average of 2-5 days
measure: the time to return of bowel function
timeFrame: through study completion, an average of 5-10 days
measure: the time to readiness for discharge
timeFrame: through study completion, an average of 7-15 days
measure: morphine requirements after surgery
timeFrame: at 24 hours after surgery
measure: morphine requirements after surgery
timeFrame: at 48 hours after surgery
measure: the residual disease after cytoreductive surgery
timeFrame: on postoperative day 1
measure: the incidence of nausea and vomiting
timeFrame: during 72 hours after surgery
measure: the incidence of postoperative hypotension
timeFrame: during 72 hours after surgery
measure: the incidence of pruritus
timeFrame: during 72 hours after surgery
measure: the incidence of drowsiness
timeFrame: during 72 hours after surgery
measure: the incidence of respiratory depression
timeFrame: during 72 hours after surgery
measure: the incidence of nystagmus
timeFrame: during 72 hours after surgery
measure: the incidence of diplopia
timeFrame: during 72 hours after surgery
measure: the incidence of hypertonia
timeFrame: during 72 hours after surgery
measure: the incidence of daymare
timeFrame: during 72 hours after surgery
measure: the incedence of neuropsychiatric symptoms
timeFrame: during 72 hours after surgery
measure: the incidence of dissociative states
timeFrame: during 72 hours after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
References: