Postoperative Sepsis in Colorectal Cancer Patients
Conditions
Interventions
Dexmedetomidine group:Dexmedetomidine
Placebo control group:Normal saline placebo
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. The study participant or their family member voluntarily agrees to participate in this study, signs the informed consent form, and demonstrates good compliance. 2. Age 18–85 years at the time of signing the informed consent form. 3. Pathologically confirmed colorectal cancer. 4. Meeting the diagnostic criteria for sepsis according to Sepsis-3: at screening and enrollment, the participant has suspected or confirmed intra-abdominal infection, with an acute increase in infection-related SOFA score of >=2 points from baseline during the same period. 5. Hospitalized in our hospital and scheduled to undergo elective or emergency abdominal surgery under general anesthesia, including colorectal cancer-related surgery or surgery related to the management of intra-abdominal infection.
Exclusion criteria
Exclusion criteria: 1. Allergy to dexmedetomidine or other a2-adrenergic agonists, or a history of severe adverse reactions to these agents. 2. Significant cardiovascular instability: heart rate <50 beats/min, Mobitz type II second-degree atrioventricular block, third-degree atrioventricular block, or sick sinus syndrome without a pacemaker. 3. Significant immunological confounding factors, including active hematological malignancy; HIV infection with CD4? T-cell count <200/µL; use of high-dose corticosteroids, immunosuppressants, biologics, cytotoxic chemotherapy, or radiotherapy within the past 4 weeks, except for patients who have completed neoadjuvant therapy and passed the appropriate washout period. 4. Pregnancy or lactation; women of childbearing potential who refuse pregnancy testing or are unwilling to use effective contraception. 5. Continuous use of dexmedetomidine or other a2-adrenergic agonists within 12 hours before enrollment and inability to discontinue such treatment. 6. Inability to provide valid informed consent, or inability to complete key postoperative sampling/follow-up at 6 h and 24 h. 7. Any condition in which the investigator judges that continued participation would pose risks greater than potential benefits or would seriously interfere with interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in peripheral blood lymphocyte subsets;Changes in peripheral blood inflammatory cytokine levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality;Incidence of delirium;ICU admission or death within 24 hours;Perioperative hemodynamic and oxygenation parameters;Infectious complications;Other complications and adverse events;ICU-free days up to day 7;Ventilation-free days and vasopressor-free days up to day 7;Reintubation or reoperation;Time to ICU admission;ICU length of stay and total hospital length of stay;Bleeding or thrombotic events;HR, MAP, and SpO? levels at the following time points: upon entering the operating room (T0), during intubation (T1), 5 minutes after surgery start (T2), and at the end of surgery (T3).; | — |
Countries
China
Contacts
Public Contactjiaxi Tang
Chongqing University Cancer Hospital
Outcome results
None listed