drugset / Trial / NCT02469961

Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block

NCT02469961 ↗

Phase 4 Completed 50 enrolled Maimonides Medical Center
RandomizedParallel-groupOpen-labelOther

Summary

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study. Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Timeline

Start
2010-10
Primary completion
2011-08
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.7 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous
Comparator Propofol Small molecule 50 ug/kg Intravenous
Comparator Propofol Small molecule 120 ug/kg Intravenous

Indications

No indication recorded.