drugset / Trial / NCT01065350

A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters

NCT01065350 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Some of these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug combination known as ketofol (ketamine/propofol admixture) during induction and compare them to propofol. If we determine that the changes produced by ketofol are favorable compared with propofol, we then will seek to test its use in the trauma setting in a subsequent randomized controlled trial.

Timeline

Start
2010-12
Primary completion
2011-03
Completion
2011-03

Outcome

Mixed primary results

paper Propofol was more likely to generate a 20% reduction in systolic blood pressure from baseline at 5 minutes (48.8% vs. 12% PMID 22743378 ↗

registry analysis (superiority or other test); Propofol vs Ketofol; p <0.001; Odds Ratio (OR) 6.87 (95% CI 2.07 to 26.15); Chi-squared; NCT01065350 ↗

registry analysis (superiority or other test); Propofol vs Ketofol; p = 0.39; Odds Ratio (OR) 1.53 (95% CI 0.52 to 4.55); Chi-squared; NCT01065350 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.75 mg/kg —
Comparator Propofol Small molecule 1.5 mg/kg —
Comparator Propofol Small molecule 2 mg/kg —

Indications