Clinical trial NCT00886275: Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit
Official title: Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Oxidative Stress
Keywords: Postoperative sedation in intensive care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patient who is older than 18 years old and less than 80 years old
* Patient who is admitted to intensive care unit with artery line
* Patient's hemodynamic status is stable under adequate management and absence of signs of shock
* Patient who has understood the inform consent and agree to participate this study

Exclusion Criteria:

* Patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock
* Patient who has a past history of allergy to study drugs
* Patient who has renal failure or requires renal replacement therapy
* Patient who has liver cirrhosis or liver failure
* Patient who has participated in any other investigational study of other drugs currently
* Female patient who is pregnant or considers breast feeding currently

Primary outcomes:
measure: Time to extubation
timeFrame: hour
Secondary outcomes:
measure: ICU Stay Weaning parameter
timeFrame: Hour
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, M.D
role: PRINCIPAL_INVESTIGATOR
References: