To hear about similar clinical trials, please enter your email below
Trial Title:
Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer
NCT ID:
NCT06624878
Condition:
Ovarian Cancer
Cytoreductive Surgery
Depressive Symptom
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Depression
Esketamine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
esketamine
Description:
0.2 mg/kg esketamine infused intravenously after induction of general anesthesia.
Arm group label:
the esketamine group
Intervention type:
Drug
Intervention name:
placebo
Description:
a placebo (an equivalent volume of normal saline) infused intravenously after induction
of general anesthesia.
Arm group label:
the placebo group
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 16, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06624878
