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.
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;
Extracted from ChiCTR intervention description
Extracted from ChiCTR intervention description