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

NCT00886275 | Completed Phase 4

• 1 other identifier: 200901037M
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to extubation

  hour

Secondary Outcomes (1)

• ICU Stay Weaning parameter

  Hour

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Dexmedetomidine, Midazolam

EXPERIMENTAL

Combination

Drug: Dexmedetomidine, Midazolam

Interventions

Dexmedetomidine 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.

Dexmedetomidine

Midazolam 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.

Midazolam

Dexmedetomidine, Midazolam 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.

Dexmedetomidine, Midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yu-Chang Yeh, M.D

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Last Updated: November 16, 2012

Record last verified: 2012-11

Locations

TW (1)