drugset / Trial / NCT02393066

Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery

NCT02393066 ↗

Phase 4 Completed 60 enrolled National Taiwan University Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 \~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 \~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment \[0h\], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.

Timeline

Start
2014-10
Primary completion
2015-07
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.1 ug/kg Intravenous
Comparator Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous
Comparator Propofol Small molecule 0.3 mg/kg Intravenous
Comparator Propofol Small molecule 1.6 mg/kg Intravenous