Prophylactic Effects of Esketamine in Surgical Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Evidences have showing that esketamine has anti-inflammatory and therapeutic effects on depression and cardiac surgery. The investigators' preliminary results suggest that combined prophylactic and therapeutic use of esketamine could decrease the plasma levels of pro-inflammatory cytokines after LPS-induced endotoxemia. The investigators also found that combined prophylactic and therapeutic use of esketamine could attenuate systemic inflammation and inflammatory multi-organ injury in mice after CLP-induced lethal sepsis.

Surgical trauma could elicit a marked inflammatory response with increased expression of pro-inflammatory cytokines, as well as postoperative immunosuppression. However, it remains unclear whether combined prophylactic and therapeutic use of esketamine could improve postoperative immunosuppression and alleviates systemic inflammatory response.

This project aims to study whether combined prophylactic and therapeutic use of esketamine could improve the decreased number of lymphocyte subsets and increased plasma pro-inflammatory cytokines.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Esketamine; Ketamine

Criteria

Inclusion Criteria:

• Patients aged 18-80 years old without restriction of gender, race, religion, creed or nationality;

• Surgery with general anesthesia operation with estimated operation time of at least 2 hours;

• Patients and/or their family members know and agree to participate in the trial.

Exclusion Criteria:

• Local anesthesia surgery;

• Being admitted to ICU immediately after surgery;

• Pregnant or breastfeeding;

• History of solid organ or bone marrow transplantation;

• Diseases that may affect immune-related indicators, including autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus, etc.), and malignant hematological tumours (leukaemia and lymphoma, etc.);

• Acute brain injury, including traumatic brain injury, subarachnoid hemorrhage, acute ischemic stroke, acute intracranial hemorrhage and acute intracranial infection;

• Chronic nephrosis;

• Acute myocardial infarction or severe heart failure (NYHA: Grade 4);

• Severe chronic liver disease (child-Pugh: Grade C);

• Deafness, aphasia, mental illness or severe cognitive impairment;

• Endotracheal intubation could not be removed within 24 hours after surgery

• Patients and/or their family members refuse to participate in the trial.