Esketamine's effect on anxiety in patients having abdominal tumor surgery
Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
This study is testing if esketamine can help reduce anxiety in patients having surgery for abdominal tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06530706 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of esketamine in reducing anxiety levels in patients undergoing abdominal tumor surgery. Patients with a Hamilton anxiety scale score of 8 or higher are randomly assigned to receive either esketamine or a placebo (normal saline) during their surgical procedure. Various scales, including the Hamilton anxiety scale, PHQ-8, QoR-15, and Athens Insomnia Scale, are utilized to assess anxiety, quality of recovery, and sleep status at multiple time points post-surgery. The goal is to determine if esketamine can provide significant relief from anxiety during the surgical experience.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 undergoing abdominal tumor surgery with moderate to severe anxiety.
Not a fit: Patients with serious mental illnesses, severe organ dysfunction, or those on antipsychotic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce anxiety in surgical patients, improving their overall surgical experience and recovery.
How similar studies have performed: While the use of esketamine for anxiety is a relatively novel approach, similar studies have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang cancer hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Wen Zhang
- Email: wendymos@126.com
- Phone: 15990145873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.