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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886275
• Other study ID #: 200901037M
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2009
• Last updated: November 15, 2012
• Start date: July 2010

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Oxidative Stress
• Sedation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to extubation		hour	Yes
Secondary	ICU Stay Weaning parameter		Hour	Yes