Comparing Dexmedetomidine and Ketamine for Inflammatory Response in Sepsis Patients
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients With Intraabdominal Sepsis: A Randomized Controlled Study
This study is testing whether Dexmedetomidine or Ketamine works better to help reduce inflammation and improve blood flow in adults recovering from surgery for severe abdominal infections.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 2 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | New Valley University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06490731 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Dexmedetomidine versus Ketamine on the inflammatory and hemodynamic responses in patients suffering from intra-abdominal sepsis. It aims to understand how these medications can influence the body's immune response and circulatory stability in critically ill patients. The study will enroll adult patients who have undergone ileus surgery and require postoperative sedation and ventilation, focusing on those with significant organ dysfunction as indicated by their SOFA scores. By comparing these two interventions, the trial seeks to identify which may offer better outcomes in managing severe sepsis.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients admitted to the ICU after ileus surgery who require postoperative sedation and ventilation due to intra-abdominal sepsis.
Not a fit: Patients with known allergies to ketamine or dexmedetomidine, or those with severe heart, renal, or liver failure, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with severe sepsis, potentially reducing mortality rates.
How similar studies have performed: While the specific combination of Dexmedetomidine and Ketamine in this context may be novel, previous studies have shown promising results with both agents in managing sepsis and its complications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Adult patients admitted to ICU after ileus surgery (perforated viscus, infarcted bowel, strangulated hernia, anastomotic leakage, diverticulitis, and intestinal obstruction), and who will be expected to require postoperative sedation and ventilation. * Abdominal sepsis was determined as organ dysfunction with a substantial change in overall SOFA score (2) ≥ 2 points because of intra-abdominal sepsis. Exclusion Criteria: * • Known allergy to ketamine, dexmedetomidine, * Confirmed pregnancy, * Heart failure (class 3 or 4 of the New York Heart Association), * Renal failure (RIFLE classification), * Liver failure (manifested by serum total protein concentration \<3 g/dl and total bilirubin \>5 mg/dl) * Known or suspected brain death. * Patients who receive neuromuscular blockers during the first 48 hours of ICU admission will also be excluded.
Where this trial is running
Asyut
- asyut University — Asyut, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Ismail Abdel Sabour, MD — NewValley University
- Study coordinator: Ahmed Ismail ABDEL sabour, MD
- Email: ahmed_ismail87@med.nvu.edu.eg
- Phone: 01097845491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.