Anxiety StateNCT06530706
Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
A study testing Esketamine and normal saline in people with Anxiety State and Esketamine, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety State, Esketamine
- What is being tested?
- Esketamine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2024to 30 Jun 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing abdominal tumor surgery;
- older than 18 years old and younger than 70 years old;
- ASA grade I-III；
- Hamilton anxiety scale ≥ 8.
Who cannot join
- Having serious mental illness before surgery or on antipsychotic medication in the two weeks before screening;
- Severe organ function lesions such as heart failure (left ventricular ejection fraction <30%), myocardial infarction, kidney failure (requiring kidney replacement therapy), liver function impairment (Child-Pugh grade C), etc.
- Patients arranged to receive general anesthesia combined with epidural anesthesia patients;
- Patients who cannot communicate, read or write due to visual, auditory, language or other reasons;
- Patients allergic to ketamine;
- Patients refused to use postoperative self-controlled intravenous analgesia pump;
- Patients refused to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.
Read the detailed description
Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score ≥ 8 were enrolled. These patients were randomly assigned to the experimental group and control group.
All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15 Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used to maintain anesthesia. The experimental group had esketamine while the control group had normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8 scale, QoR-15 Scale were collected 3 days after surgery and 1 month after surgery.
- Conditions
- Anxiety State, Esketamine
- Being tested
- Esketamine, normal saline
- Keywords
- esketamine, anxiety state
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called Experimental group
Esketamine 0.2mg/kg was pumped slowly after intubation, followed by 0.1mg/kg pumped until the end of the operation. In the PCIA pump, esketamine 1mg/kg was added to the sufentanil.
normal salineDrug
Also called Control Group
Same volume of normal saline was pumped slowly after intubation, followed by the same volume of NS until the end of the operation. In the PCIA pump, only sufentanil was used.
| Study group | Role | What they receive |
|---|---|---|
| Experiment group | Experimental | Esketamine 0.2mg/kg was given slowly after intubation, and then 0.1mg/kg/h was pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, with sufentanil combined with esketamine 1mg/kg in a PCIA device. Receives: Drug: Esketamine |
| Control group | Placebo comparator | Same volume of normal saline was given slowly after intubation, and then pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, without esketamine in the PCIA device. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether esketamine can reduce anxiety status in patients with anxiety
assessed by Hamilton anxiety scale. The score ranges from 0 to 56, while the higher score means a more anxious state.
Measured: 1 day before surgery, 3 days after surgery, 1 month after surgery
Secondary outcomes (2)
To explore whether esketamine can improve sleep status
assessed by Athens Insomnia Scale. Athens Insomnia Scale ranges from o to 24, with a higher score means a worse sleep status.
Measured: 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery
To explore whether esketamine can improve life quality
assessed by QoR-15 (quality of recovery-15). The score ranges from 0 (bad quality) to 150 (good quality).
Measured: 1 day before surgery, 3 days after surgery, 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start5 Aug 2024
- Primary completion30 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Zhang, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530706
- Sponsor's protocol ID
- IRB-2024-327（IIT）
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
- ClinicalTrials.gov ID
- NCT06530706
- Acronym / sponsor ID
- IRB-2024-327（IIT）
- Conditions
- Anxiety State, Esketamine
- Keywords
- esketamine, anxiety state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 31 Jul 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.
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.
Detailed description
Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score ≥ 8 were enrolled. These patients were randomly assigned to the experimental group and control group.
All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15 Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used to maintain anesthesia. The experimental group had esketamine while the control group had normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8 scale, QoR-15 Scale were collected 3 days after surgery and 1 month after surgery.
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 |
|---|---|---|
| Experiment group | Experimental | Drug: EsketamineEsketamine 0.2mg/kg was given slowly after intubation, and then 0.1mg/kg/h was pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, with sufentanil combined with esketamine 1mg/kg in a PCIA device. |
| Control group | Placebo comparator | Drug: normal salineSame volume of normal saline was given slowly after intubation, and then pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, without esketamine in the PCIA device. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing abdominal tumor surgery;
- older than 18 years old and younger than 70 years old;
- ASA grade I-III；
- Hamilton anxiety scale ≥ 8.
Key exclusion criteria (7 listed)
- Having serious mental illness before surgery or on antipsychotic medication in the two weeks before screening;
- Severe organ function lesions such as heart failure (left ventricular ejection fraction <30%), myocardial infarction, kidney failure (requiring kidney replacement therapy), liver function impairment (Child-Pugh grade C), etc.
- Patients arranged to receive general anesthesia combined with epidural anesthesia patients;
- Patients who cannot communicate, read or write due to visual, auditory, language or other reasons;
- Patients allergic to ketamine;
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 |
|---|---|---|
| EsketamineAlso: Experimental groupEsketamine 0.2mg/kg was pumped slowly after intubation, followed by 0.1mg/kg pumped until the end of the operation. In the PCIA pump, esketamine 1mg/kg was added to the sufentanil. | Drug | Experiment group |
| normal salineAlso: Control GroupSame volume of normal saline was pumped slowly after intubation, followed by the same volume of NS until the end of the operation. In the PCIA pump, only sufentanil was used. | Drug | Control group |
Primary outcome
Whether esketamine can reduce anxiety status in patients with anxiety
Time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery
assessed by Hamilton anxiety scale. The score ranges from 0 to 56, while the higher score means a more anxious state.
2 secondary outcomes
To explore whether esketamine can improve sleep status
Time frame: 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery
To explore whether esketamine can improve life quality
Time frame: 1 day before surgery, 3 days after surgery, 1 month 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 16 Sep 2025.
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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 and normal saline in people with Anxiety State and Esketamine, 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 4 inclusion and 7 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 16 Sep 2025. 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?
Whether esketamine can reduce anxiety status in patients with anxiety (time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery). 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 16 Sep 2025.