Clinical trial

Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients With Intraabdominal Sepsis: A Randomized Controlled Study

Name
New valley anesthesia 4
Description
Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it .
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-08-01
Trial end
2026-01-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Dexmedetomidine
Patients will receive dexmedetomidine
Arms:
Patients will receive dexmedetomidine
Ketamine
patients Will receive ketamine
Arms:
Patients will receive ketamine
Size
2
Primary endpoint
blood pressure
48 hours
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2, 'type': 'ESTIMATED'}}
Updated at
2024-07-08

1 organization

1 product

1 drug

1 indication