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

NCT ID: NCT06530706

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Anxiety State; Esketamine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Experimental group; Control Group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen Zhang

attending, principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IRB-2024-327（IIT）

Identifier Type: -

Identifier Source: org_study_id