Clinical TrialDepressive DisordersAnxiety DisordersEsketamineNot yet recruiting

Effect of sub - anesthetic dose of esketamine on the incidence of postoperative anxiety and depression in patients with thyroid cancer and breast cancer: A prospective, single - center clinical study

This prospective, single-centre interventional trial in China (n=196 planned; 98 per group) is a Phase 0 parallel-group study evaluating whether subanaesthetic esketamine reduces postoperative anxiety and depression in adults undergoing surgery for thyroid cancer or breast cancer. Participants are randomised to receive either an esketamine infusion prepared at 2.5 mg/ml and administered at 0.25 mg/kg/h, or 0.9% normal saline at 0.1 ml/kg/h as the control comparator. The study population includes both sexes aged 18 years and older. The primary outcome is the incidence of postoperative anxiety and depression in both groups within 72 hours after surgery. Secondary outcomes include postoperative quality of recovery, assessed using the QoR-15 at 48 hours, postoperative pain scores at 48 and 72 hours, and healthcare utilisation measures including length of hospital stay and total cost from surgery to discharge. The trial is designed to assess whether perioperative esketamine can improve early psychological and recovery outcomes in patients with cancer surgery.

Target Enrollment
Not specified
Study Type
Phase I interventional
Design
Non-randomized

Study Arms & Interventions

Experimental

experimental

experimental group:Prepare the esketamine injection into a concentration of 2.5mg/ml, and then administer it by infusion at a rate of 0.25mg/kg/h.;Control group:Administer 0.9% normal saline at a rate of 0.1 ml/kg/h through infusion.;

Interventions

  • Esketamine

    Extracted from ChiCTR intervention description

Participants

Ages
18?
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. Age >= 18 years old;2. Planning for elective surgeries for thyroid cancer and breast cancer;3. ASA classification: I-III grades;4. Voluntary signing of the informed consent form.

Exclusion Criteria

  • Exclusion criteria: 1. The preoperative diagnosis indicated a history of anxiety and depression disorders.2. Patients allergic to esketamine;3. Three months later, they will participate in other researches.4. Intellectual or mental disorders, making it impossible to cooperate with the patient;5. Patients who refuse to sign the consent form.

Study Details

Locations

China

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