Clinical TrialParallelKetamineEsketamineNot yet recruiting

The influence of esketamine on postoperative sleep disorders in patients with thyroid cancer

This parallel, Phase IV interventional trial in China (n=120) is evaluating whether esketamine can reduce postoperative sleep disorders in adults with thyroid cancer. Participants are allocated to three groups: low-dose esketamine (0.3 mg/kg intravenously before anaesthesia induction), high-dose esketamine (0.5 mg/kg intravenously before anaesthesia induction), or an equivalent volume of intravenous normal saline as control. The study includes men and women aged 18 to 60 years. The primary outcomes are insomnia severity measured by the Athens Insomnia Scale (AIS) and assessed postoperatively at the prespecified follow-up timepoints. Secondary outcomes include sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ), anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS), and pain intensity measured with the Numerical Rating Scale (NRS). This trial is designed to clarify whether perioperative esketamine improves sleep-related recovery after thyroid cancer surgery compared with placebo, and whether the higher dose provides additional benefit. The study is sponsored by the Affiliated Hospital of Zunyi Medical University.

Target Enrollment
120 participants
Study Type
Phase IV interventional
Design
Non-randomized

Study Arms & Interventions

Experimental

experimental

Group L:Before anesthesia induction, 0.3mg/kg of esketamine was intravenously injected.;Group H:Before anesthesia induction, 0.5mg/kg of esketamine was intravenously injected.;Group C:Intravenous injection of an equal amount of normal saline before anesthesia induction;

Interventions

  • Ketamine

    Extracted from ChiCTR intervention description

  • Esketamine

    Extracted from ChiCTR intervention description

Participants

Ages
1860
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. Age 18-60 years old, gender unrestricted;2. ASA classification grade I - II;3. BMI 18-28 kg/m^2;4. Informed consent to the surgical and anesthesia plans, voluntarily signing the surgical informed consent form and the anesthesia informed consent form.

Exclusion Criteria

  • Exclusion criteria: 1. Severe insomnia symptoms before the operation, with a preoperative Pittsburgh Sleep Quality Index (PSQI) > 7;2. History of thyroid surgery, hyperthyroidism or hypothyroidism;3. Severe organic lesions in heart, lung, liver and kidney functions [combined with abnormal functions of important organs such as heart, liver and kidney (NYHA classification > grade 2; liver failure or Child-Pugh score B or C; glomerular filtration rate < 30 ml/min)];4. Previously diagnosed with mental disorders;5. Those with contraindications to general anesthesia and esketamine injection;6. Long-term (at least 3 consecutive months) use of opioid drugs, sedative drugs, antidepressant drugs or anti-anxiety drugs;7. Patients who refuse to participate in this clinical trial.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment120 participants
  • Timeline
    Start: 2026-05-25
  • Compounds

Study Team

Sponsors & Collaborators

Locations

China