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

To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.

Study Overview

• Status: Completed
• Conditions: Anxiety State; Esketamine
• Intervention / Treatment: Drug: Esketamine; Drug: normal saline

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 Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Experimental group
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; 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.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day before surgery, 3 days after surgery, 1 month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	1 day before surgery, 3 days after surgery, 1 month after surgery

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: esketamine; anxiety state
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Pharmaceutical Preparations; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Crystalloid Solutions; Isotonic Solutions; Solutions; Esketamine; Control Groups; Saline Solution
• Other Study ID Numbers: IRB-2024-327（IIT）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No