NCT00886275

Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In intensive care unit, patients suffered pain and anxiety from mechanical ventilation, presence of endotracheal tube, central venous catheter, postoperative wound, and invasive procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Memis et al had found that dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation. Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ dysfunction. The goal of this study is to compare the effects of dexmedetomidine and midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and microcirculation.

Conditions

• Sedation
• Oxidative Stress

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	The loading dose of dexmedetomidine is 0.5 mcg/kg over 10 minutes as needed. Then, continuous infusion of 0.2-0.7 mcg/kg/h dexmedetomidine is used to maintain RASS between 0 to -3.
DRUG	Midazolam	The loading dose of midazolam is 0.05 mg/kg over 10 minutes as needed. Then, continuous infusion of 20-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
DRUG	Dexmedetomidine, Midazolam	The loading doses are dexmedetomidine 0.25 mcg/kg and 0.025 mg/kg of midazolam over 10 minutes. Then, continuous infusion of 0.1-0.7 mcg/kg/h dexmedetomidine and 10-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-04-01
• First posted: 2009-04-22
• Last updated: 2012-11-16

Locations

1 site across 1 country: Taiwan