drugset / Trial / NCT01269918

A Comparison of Remifentanil and Dexmedetomidine for Craniotomy Perioperative Hemodynamics and Postoperative Pain

NCT01269918 ↗

Completed 142 enrolled The Cleveland Clinic
RandomizedParallel-groupDouble-blindTreatment

Summary

This will be a randomized blinded clinical trial. Patients will be randomized to receive either a remifentanil or dexmedetomidine infusion for general anesthesia. The anesthesia team will know the result of randomization at induction. Data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive till they are discharged from the PACU when they will have the option to be unblinded. The Data Safety and -Toxicity Committee will review all serious adverse events and toxicity reports as well as annual reviews.

Timeline

Start
2011-07
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.2 ug/kg —
Comparator Dexmedetomidine Other / unclassified 0.7 ug/kg —
Comparator Remifentanil Small molecule 0.08 ug/kg —
Comparator Remifentanil Small molecule 0.15 ug/kg —

Indications