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

University of Chinese Academy Sciences

Status: Completed

Conditions: Esketamine; Anxiety State

Treatments: Drug: Esketamine; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06530706

IRB-2024-327（IIT）

Details and patient eligibility

About

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

Full 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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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185 participants in 2 patient groups, including a placebo group

Experiment group

Experimental group

Description:

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.

Treatment:

Drug: Esketamine

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: normal saline