Effects of Esketamine on inflammatory mediators, postoperative depression-like mood and intestinal flora in patients undergoing radical operation for lung cancer
This parallel, interventional Phase 4 trial in China (n=80) is recruiting adults aged 18–65 undergoing radical surgery for lung cancer. Participants are allocated to intravenous esketamine or intravenous saline as the control comparator. The study is designed to assess whether perioperative esketamine influences postoperative depressive symptoms, inflammatory mediators, and intestinal flora in this surgical population. The primary outcomes are the Patient Health Questionnaire-9 (PHQ-9) score and intestinal flora, though specific assessment timepoints are not provided in the registry entry. Secondary outcomes include postoperative pain measured by the Visual Analogue Scale (VAS) and inflammatory markers. The trial is sponsored by the Department of Anaesthesiology at the Affiliated Hospital of Southwest Medical University. Overall, this study aims to explore both psychological and biological effects of esketamine in patients with lung cancer after radical operation, with saline used as the comparator to help clarify any treatment-related changes in mood, inflammation, and gut microbiota.
Study Arms & Interventions
Experimental
experimentalgroup E:Intravenous esketamine;group C:Intravenous saline;
Interventions
- Esketamine
Extracted from ChiCTR intervention description
Participants
Inclusion Criteria
- Inclusion criteria: 1. Patients with radical resection of lung cancer;
- 2. Gender limitation;
- 3. Aged 18-65 years;
- 4. ASA Grade ?-?.
Exclusion Criteria
- Exclusion criteria: 1. Severe uncontrolled hypertension (SBP=180mmHg or DBP=110mmgHg);
- 2. Neuropsychiatric diseases;
- 3. Inability to understand or use VAS pain scores;
- 4. Unable to understand or use the PHQ9 depression scale score;
- 5. Esketamine drug allergy.
Study Details
- StatusRecruiting
- PhasePhase IV
- Typeinterventional
- DesignNon-randomized
- TimelineStart: 2023-03-28
- Compound
- Topic
Study Team
Sponsors & Collaborators
- First Affiliated Hospital of Chongqing Medical UniversityPrimary Sponsor