Ovarian CancerNCT06624878
Esketamine for Prevention of Depression After Cytoreductive Surgery in Ovarian Cancer
A study testing esketamine in people with Ovarian Cancer and Cytoreductive Surgery, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer, Cytoreductive Surgery, Depressive Symptom
- What is being tested?
- esketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 568 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 14 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing cytoreductive surgery for ovarian cancer under general anesthesia
- ASA physical status I-III
- Ages 18-80 years
Who cannot join
- Patients taking anti-psychotic medications
- Contraindications to esketamine
- Language barrier
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Esketamine for Prevention of Depressive Symptoms After Cytoreductive Surgery in Ovarian Cancer: a Controlled, Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Ovarian Cancer, Cytoreductive Surgery, Depressive Symptom
- Being tested
- esketamine, placebo
- Medical subject headings
- Ovarian Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamineDrug
0.2 mg/kg esketamine infused intravenously after induction of general anesthesia.
placeboDrug
a placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| the esketamine group | Experimental | Not described Receives: Drug: esketamine |
| the placebo group | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on postoperative day 3
Secondary outcomes (25)
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.
Measured: Baseline (before surgery), on postoperative day 30
the incidence of sleep disturbance in ovarian cancer
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at 1, 24, 48, 72 hours after surgery
the lengh of postoperative ICU admission
Measured: through study completion, an average of 1-5 days
the time to initiation of postoperative chemotherapy
Measured: through study completion, an average of 5-20 days
the postoperative complications of ovarian cancer
The complications are assessed using the Claviene-Dindo score.
Measured: within 30 days after surgery
the time to walk after surgery
Measured: through study completion, an average of 2-5 days
the time to return of bowel function
Measured: through study completion, an average of 5-10 days
the time to readiness for discharge
Measured: through study completion, an average of 7-15 days
morphine requirements after surgery
Measured: at 24 hours after surgery
morphine requirements after surgery
Measured: at 48 hours after surgery
the residual disease after cytoreductive surgery
The residual disease is assessed using the propotion of optimal debulking.
Measured: on postoperative day 1
the incidence of nausea and vomiting
Measured: during 72 hours after surgery
the incidence of postoperative hypotension
Measured: during 72 hours after surgery
the incidence of pruritus
Measured: during 72 hours after surgery
the incidence of drowsiness
Measured: during 72 hours after surgery
the incidence of respiratory depression
Measured: during 72 hours after surgery
the incidence of nystagmus
Measured: during 72 hours after surgery
the incidence of diplopia
Measured: during 72 hours after surgery
the incidence of hypertonia
Measured: during 72 hours after surgery
the incidence of daymare
Measured: 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.
Measured: 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.
Measured: during 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 Oct 2024
- Primary completion14 Jan 2026
- Study completion14 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Bin, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624878
- Sponsor's protocol ID
- IRB-2024-885 (IIT)
- Status last verified
- Feb 2026
- First submitted
- 1 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data on ClinicalTrials.gov, and data sharing will be always available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Esketamine for Prevention of Depressive Symptoms After Cytoreductive Surgery in Ovarian Cancer: a Controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06624878
- Acronym / sponsor ID
- IRB-2024-885 (IIT)
- Conditions
- Ovarian Cancer, Cytoreductive Surgery, Depressive Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Feb 2026 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the esketamine group | Experimental | Drug: esketamine |
| the placebo group | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing cytoreductive surgery for ovarian cancer under general anesthesia
- ASA physical status I-III
- Ages 18-80 years
Key exclusion criteria (4 listed)
- Patients taking anti-psychotic medications
- Contraindications to esketamine
- Language barrier
- Inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esketamine0.2 mg/kg esketamine infused intravenously after induction of general anesthesia. | Drug | the esketamine group |
| placeboa placebo (an equivalent volume of normal saline) infused intravenously after induction of general anesthesia. | Drug | the placebo group |
Primary outcome
the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer
Time frame: on postoperative day 3
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.
25 secondary outcomes
the incidence of depressive symptoms in ovarian cancer
Time frame: Baseline (before surgery), on postoperative day 30
the incidence of sleep disturbance in ovarian cancer
Time frame: Baseline (before surgery), on postoperative day 3 and on postoperative day 30
the incidence of anxiety in ovarian cancer
Time frame: Baseline (before surgery)
the postoperative recovery of ovarian cancer
Time frame: Baseline (before surgery), on postoperative day 3
postoperative pain score at rest and coughing pain
Time frame: at 1, 24, 48, 72 hours after surgery
the lengh of postoperative ICU admission
Time frame: through study completion, an average of 1-5 days
the time to initiation of postoperative chemotherapy
Time frame: through study completion, an average of 5-20 days
the postoperative complications of ovarian cancer
Time frame: within 30 days after surgery
the time to walk after surgery
Time frame: through study completion, an average of 2-5 days
the time to return of bowel function
Time frame: through study completion, an average of 5-10 days
the time to readiness for discharge
Time frame: through study completion, an average of 7-15 days
morphine requirements after surgery
Time frame: at 24 hours after surgery
morphine requirements after surgery
Time frame: at 48 hours after surgery
the residual disease after cytoreductive surgery
Time frame: on postoperative day 1
the incidence of nausea and vomiting
Time frame: during 72 hours after surgery
the incidence of postoperative hypotension
Time frame: during 72 hours after surgery
the incidence of pruritus
Time frame: during 72 hours after surgery
the incidence of drowsiness
Time frame: during 72 hours after surgery
the incidence of respiratory depression
Time frame: during 72 hours after surgery
the incidence of nystagmus
Time frame: during 72 hours after surgery
the incidence of diplopia
Time frame: during 72 hours after surgery
the incidence of hypertonia
Time frame: during 72 hours after surgery
the incidence of daymare
Time frame: during 72 hours after surgery
the incedence of neuropsychiatric symptoms
Time frame: during 72 hours after surgery
the incidence of dissociative states
Time frame: during 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share data on ClinicalTrials.gov, and data sharing will be always available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esketamine in people with Ovarian Cancer and Cytoreductive Surgery, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of postoperative depressive symptoms after cytoreductive surgery in ovarian cancer (time frame: on postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.