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

Zhejiang Cancer Hospital185 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

185

Conditions

Anxiety State Esketamine

Interventions

EsketamineDRUG

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.

normal salineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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

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

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

Data from ClinicalTrials.gov

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