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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the esketamine group | Experimental |
| |
| the placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esketamine | Drug | 0.2 mg/kg esketamine infused intravenously after induction of general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer | The postoperative depressive symptoms are assessed using the preoperative Patient Health Questionnaire 9 (PHQ-9) scale. The range of this scale is 0-27, and a standard threshold score of 10 or higher indicates symptoms of depression. | on postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of depressive symptoms in ovarian cancer | The PHQ-9 was also used to assess the depressive symptoms.The range of this scale is 0-27, and a standard threshold score of 10 or higher indicates symptoms of depression. | Baseline (before surgery), on postoperative day 30 |
| the incidence of sleep disturbance in ovarian cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang cancer hospital | Hangzhou | Zhejiang | 310022 | China |
We will share data on ClinicalTrials.gov, and data sharing will be always available.
starting about 6 months after publication
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D003863 | Depression |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| placebo | Drug | a placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia. |
|
The sleep disturbance are assessed using the Athens Insomnia Scale (AIS). The range of this scale is 0-24, and a standard threshold score of 7 or higher indicates sleep disturbance. |
| Baseline (before surgery), on postoperative day 3 and on postoperative day 30 |
| the incidence of anxiety in ovarian cancer | The anxiety symptom is assessed using the Generalized Anxiety Disorder-7 (GAD-7). The range of this scale is 0-21, and a standard threshold score of 10 or higher indicates anxiety. | Baseline (before surgery) |
| the postoperative recovery of ovarian cancer | The postoperative recovery is assessed using the quality of recovery-15 questionnaire (QoR-15) .The QoR-15 has 15 questions. Each question is rated on a 10-point scale, ranging from 0 (none of the time or poor) to 10 (all of the time or excellent). The maximum score (best recovery) is 150. | Baseline (before surgery), on postoperative day 3 |
| postoperative pain score at rest and coughing pain | The postoperative pain at rest and during coughing are assessed by NRS score with a range of 0 to 10 (0=no pain, 10=the worst possible pain). | at 1, 24, 48, 72 hours after surgery |
| the lengh of postoperative ICU admission | through study completion, an average of 1-5 days |
| the time to initiation of postoperative chemotherapy | through study completion, an average of 5-20 days |
| the postoperative complications of ovarian cancer | The complications are assessed using the Claviene-Dindo score. | within 30 days after surgery |
| the time to walk after surgery | through study completion, an average of 2-5 days |
| the time to return of bowel function | through study completion, an average of 5-10 days |
| the time to readiness for discharge | through study completion, an average of 7-15 days |
| morphine requirements after surgery | at 24 hours after surgery |
| morphine requirements after surgery | at 48 hours after surgery |
| the residual disease after cytoreductive surgery | The residual disease is assessed using the propotion of optimal debulking. | on postoperative day 1 |
| the incidence of nausea and vomiting | during 72 hours after surgery |
| the incidence of postoperative hypotension | during 72 hours after surgery |
| the incidence of pruritus | during 72 hours after surgery |
| the incidence of drowsiness | during 72 hours after surgery |
| the incidence of respiratory depression | during 72 hours after surgery |
| the incidence of nystagmus | during 72 hours after surgery |
| the incidence of diplopia | during 72 hours after surgery |
| the incidence of hypertonia | during 72 hours after surgery |
| the incidence of daymare | during 72 hours after surgery |
| the incedence of neuropsychiatric symptoms | The neuropsychiatric symptoms are assessed using BPRS-4. The range of this scale is 0-28, and a standard threshold score of 5 or higher indicates symptoms of neuropsychiatric symptoms. | during 72 hours after surgery |
| the incidence of dissociative states | The dissociative states are assessed using the CADSS-6. The range of this scale is 0-24, and a standard threshold score of 3 or higher indicates symptoms of dissociative states. | during 72 hours after surgery |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |