CClinicalTrials.gg
CompletedNCT06530706Updated Sep 16, 2025

Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery

An interventional study of Esketamine and normal saline in Anxiety State and Esketamine, sponsored by Zhejiang Cancer Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Zhejiang Cancer Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anxiety State
  • Esketamine

Browse trials for

Keywords

  • esketamine
  • anxiety state
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 185 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing abdominal tumor surgery;
  • older than 18 years old and younger than 70 years old;
  • ASA grade I-III;
  • Hamilton anxiety scale ≥ 8.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Experiment group

    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.

    Drug: Esketamine

  • Placebo comparator
    Control group

    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.

    Drug: normal saline

Interventions

  • DrugEsketamine

    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.

    Also known as: Experimental group

  • Drugnormal saline

    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.

    Also known as: Control Group

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery

Secondary outcomes

  1. 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.

    Time frame: 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery

  2. 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).

    Time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery

07

Study locations

1 site
  • Zhejiang cancer hospital
    Hangzhou, Zhejiang, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06530706
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Wen Zhang (attending, principle investigator, Zhejiang Cancer Hospital) — Principal investigator
First posted
Jul 31, 2024
Start date
Aug 5, 2024
Primary completion
May 30, 2025
Completion
Jun 30, 2025
Last update
Sep 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion