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

NCT ID: NCT00886275

Last Updated: 2012-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

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.

Conditions

Sedation; Oxidative Stress

Keywords

Postoperative sedation in intensive care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

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

Combination

Group Type: EXPERIMENTAL

Dexmedetomidine, Midazolam

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chang Yeh, M.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

200901037M

Identifier Type: -

Identifier Source: org_study_id