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

NCT06530706 | Completed

• 1 other identifier: IRB-2024-327（IIT）
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety State; Esketamine

Keywords

esketamine; anxiety state

Outcome Measures

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.

  1 day before surgery, 3 days after surgery, 1 month after surgery

Secondary Outcomes (2)

• To explore whether esketamine can improve 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

  1 day before surgery, 3 days after surgery, 1 month after surgery

Study Arms (2)

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.

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.

Drug: normal saline

Interventions

Esketamine 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.

Also known as: Experimental group

Experiment group

normal saline 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.

Also known as: Control Group

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Esketamine; Saline Solution; Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending, principle investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: July 31, 2024
• Study Start: August 5, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)