DepressionNCT07374198
Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression
A study testing Esketamine 0.3mg/kg and normal saline in people with Depression and Anxiety, run by Chinese PLA General Hospital.
Trial summary
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients with Mild-to-Severe Depression Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Anxiety, S-ketamine
- What is being tested?
- Esketamine 0.3mg/kg and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 18 Jan 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Scheduled to undergo elective breast cancer resection surgery.
- American Society of Anesthesiologists (ASA) physical status classification of I-III.
- Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form.
- Female patients with mild to severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥8)
- Anticipated anesthesia duration greater than 90 minutes.
Who cannot join
- Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders .
- Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use .
- Patients with an MMSE score <18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) .
- Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) .
- Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) .
- Patients with elevated intracranial or intraocular pressure.
Show all 10Show fewer
- Patients with untreated or inadequately treated hyperthyroidism .
- Patients with a known allergy to the drugs involved in this study .
- Patients unable to complete the assessment scales required by this study.
- Patients who are currently participating in other clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression: A Randomized Controlled Trial
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients with Mild-to-Severe Depression
- Conditions
- Depression, Anxiety, S-ketamine, Breast Cancer
- Being tested
- Esketamine 0.3mg/kg, normal saline
- Medical subject headings
- Depression, Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine 0.3mg/kgDrug
A single intravenous bolus of 0.3 mg/kg of esketamine is administered during anesthesia induction, and the infusion is completed over 40 minutes.
normal salineDrug
Receiving the same volume of normal saline during induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine group | Experimental | Patients who undergo general anesthesia using esketamine. Receives: Drug: Esketamine 0.3mg/kg |
| Control group | Placebo comparator | Patients who undergo general anesthesia without esketamine Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative anxiety and depreession
Perioperative anxiety and depreession The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.
Measured: Preoperative day 1, postoperative day 3, day 7 and day 30
Secondary outcomes (6)
Postoperative Sleep Quality
Postoperative sleep quality was assessed using the Insomnia Severity Index (ISI). The ISI is a simple tool used to screen for insomnia and consists of 7 items to assess the nature and symptoms of the subject\'s sleep disorder on a 5-point Likert scale, with each item scored from 0 to 4 and the total score ranging from 0 to 28, with higher scores indicating greater severity of insomnia. The sum of the scores with 0-7 indicating insomnia without clinical significance, 8-14 indicating subclinical insomnia, 15-21 indicating clinical insomnia (moderate), 22-28 indicating 'clinical insomnia (moderate), and 22-28 indicating clinical insomnia (moderate). A score of 8 to 14 indicates subclinical insomnia, a score of 15 to 21 indicates clinical insomnia (moderate), and a score of 22 to 28 indicates clinical insomnia (severe).
Measured: Preoperative day 1, postoperative day 3, day 7 and day 30]
Delirium
Delirium was assessed using a combination of the 3-Minute Diagnostic Interview for CAM (3D-CAM) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patients in the general ward were assessed using the 3D-CAM, while patients in the intensive care unit were assessed using the CAM-ICU. Delirium consists of four main features: acute altered mental status or fluctuating level of consciousness, inattention, disorganized thinking, and altered level of consciousness. Patients were diagnosed with postoperative delirium if both the first and second features were present, and either the third or fourth feature was also present.
Measured: Within 7 days after surgery
PONV
Postoperative nausea and vomiting (PONV) were assessed using a visual analogue scale (VAS). This scale consists of a 10-centimeter straight line, with 0 indicating no nausea and vomiting, and 10 indicating the most extreme level of nausea and vomiting that can be endured. The severity of PONV is categorized as follows: mild (1 to 4), moderate (5 to 6), and severe (7 to 10).
Measured: Within 2 days after extubation
Postoperative Recovery Quality
Postoperative quality of recovery was evaluated using the Chinese version of the Quality of Recovery-15 (QoR-15) score. This assessment tool comprises 15 items, each scored on a 10-point scale. The total score ranges from 0 to 150, with 0 indicating poor recovery and 150 signifying an excellent quality of recovery.
Measured: Postoperative day 3, day 7 and day 30
Postoperative Pain
Assessment was conducted using the Numerical Rating Scale (NRS) for pain, which ranges from 0 to 10. On this scale, a score of 0 represents the absence of pain, while a score of 10 represents the most severe pain.
Measured: Postoperative day , day 7 and day 30
Postoperative Quality of Life
Postoperative quality of life was assessed using the EuroQol 5-Dimension questionnaire (EQ-5D). This instrument evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For the descriptive system, each dimension is typically rated using a three-level scale (no problems, some problems, extreme problems) or a five-level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).The responses are combined to form a 5-digit health state profile (e.g., 11111 for no problems in any dimension). This profile is then converted into a single summary number called the EQ-5D index score, using a country-specific value set. The theoretical range of the index score is approximately from -0.594 (worst imaginable health state, considered worse than death) to 1.0 (perfect health), with 0 representing a health state equivalent to death. Therefore, a higher EQ-5D index score indicates a better quality of life.
Measured: Postoperative day 3,day 7 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start18 Jan 2026 (estimated)
- Primary completion18 Jan 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374198
- Sponsor's protocol ID
- PLAGH-RCT-Esket-MTOSBC
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Intraoperative Esketamine Infusion on Perioperative Negative Emotions in Breast Cancer Surgery Patients With Mild-to-Severe Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07374198
- Acronym / sponsor ID
- PLAGH-RCT-Esket-MTOSBC
- Conditions
- Depression, Anxiety, S-ketamine, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 18 Jan 2026 (estimated)
- Primary completion
- 18 Jan 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jan 2026 (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.
A Dual-Center, Randomized, Controlled, Blinded, Prospective Study on the Effects of Esketamine on Perioperative Negative Emotions in Breast Cancer Surgery Patients with Mild-to-Severe Depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine group | Experimental | Drug: Esketamine 0.3mg/kgPatients who undergo general anesthesia using esketamine. |
| Control group | Placebo comparator | Drug: normal salinePatients who undergo general anesthesia without esketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Scheduled to undergo elective breast cancer resection surgery.
- American Society of Anesthesiologists (ASA) physical status classification of I-III.
- Clearly understand and voluntarily agree to participate in the study, and sign the informed consent form.
- Female patients with mild to severe depressive symptoms (defined as a Hospital Anxiety and Depression Scale-Depression subscale score of ≥8)
Key exclusion criteria (10 listed)
- Patients with significant preoperative abnormalities in cardiac, pulmonary, hepatic, or renal function, or coagulation disorders .
- Patients taking antipsychotics, antidepressants, or glucocorticoids, or with a history of alcohol abuse or illicit drug use .
- Patients with an MMSE score <18, dementia, intellectual disability, or those unable to communicate (e.g., coma, severe dementia, hearing or language impairment) .
- Patients with a history of psychiatric or neurological disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) .
- Patients with poorly controlled or untreated hypertension (≥180/110 mmHg) .
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 |
|---|---|---|
| Esketamine 0.3mg/kgA single intravenous bolus of 0.3 mg/kg of esketamine is administered during anesthesia induction, and the infusion is completed over 40 minutes. | Drug | Esketamine group |
| normal salineReceiving the same volume of normal saline during induction of anesthesia. | Drug | Control group |
Primary outcome
Perioperative anxiety and depreession
Time frame: Preoperative day 1, postoperative day 3, day 7 and day 30
Perioperative anxiety and depreession The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.
6 secondary outcomes
Postoperative Sleep Quality
Time frame: Preoperative day 1, postoperative day 3, day 7 and day 30]
Delirium
Time frame: Within 7 days after surgery
PONV
Time frame: Within 2 days after extubation
Postoperative Recovery Quality
Time frame: Postoperative day 3, day 7 and day 30
Postoperative Pain
Time frame: Postoperative day , day 7 and day 30
Postoperative Quality of Life
Time frame: Postoperative day 3,day 7 and day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine 0.3mg/kg and normal saline in people with Depression and Anxiety, run by Chinese PLA General Hospital.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WEIDONG MI (133810829, wwdd1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative anxiety and depreession (time frame: Preoperative day 1, postoperative day 3, day 7 and day 30). 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 28 Jan 2026.