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OpenTrials
Completed

NCT Number: NCT06530706

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.

Completed

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Experimental 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.

Other names: Control Group

Primary outcomes

  1. Whether esketamine can reduce anxiety status in patients with anxiety

    Time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery

    assessed by Hamilton anxiety scale. The score ranges from 0 to 56, while the higher score means a more anxious state.

Secondary outcomes

  1. To explore whether esketamine can improve sleep status

    Time frame: 1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery

    assessed by Athens Insomnia Scale. Athens Insomnia Scale ranges from o to 24, with a higher score means a worse sleep status.

  2. To explore whether esketamine can improve life quality

    Time frame: 1 day before surgery, 3 days after surgery, 1 month after surgery

    assessed by QoR-15 (quality of recovery-15). The score ranges from 0 (bad quality) to 150 (good quality).

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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