Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy

Microcirculation Clinical Trial

Official title:

Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01179438
• Other study ID #: 201003036M
• Status: Withdrawn
• Phase: Phase 4
• First received: August 9, 2010
• Last updated: December 6, 2012
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine administration for minor procedure, such as extracorporeal shock wave lithotripsy, provides good quality of sedation and analgesia. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Extracorporeal shock wave lithotripsy may cause pain and result in tachycardia and vasoconstriction-related hypertension. Surgical or procedural stress may induce inflammation and it may cause further microthrombosis. Both vasoconstriction and microthrombosis will alter the microcirculatory status. Dysfunction of microcirculation may impair tissue perfusion and result in organ dysfunction. Dexmedetomidine may induce vasodilation by slow intravenous infusion for sedation. Dexmedetomidine may also reduce inflammation. After reviewing the literature, the investigators found that the effect of dexmedetomidine on microcirculation was not well investigated. By application of the non-invasive technique of sidestream dark field imaging, the investigators can investigate the vessel density, percentage of perfused vessels, and microvascular flow index on sublingual vessels.

The goal of this study is to identify the effect of dexmedetomidine on sublingual microcirculation in patient undergoing extracorporeal shock wave lithotripsy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient who is older than 18 years old and less than 75 years old

• Patient who receive extraproporeal shock wave lithotripsy with ASA class I or II

• 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 s dexmedetomidine

• Patient who has history of cardiovascular, renal or hepatic dysfunction

• Patient who has participated in any other investigational study of other drugs currently

• Female patient who is pregnant or considers breast feeding currently

• Patient who has suspected full stomach

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Microcirculation

Intervention

Drug:
• Dexmedetomidine
The loading does of 0.5 mcg/kg dexmedetomidine is infused over 10 minutes. The following maintenance does of dexmedetomidine is 0.5 mcg/kg/hour.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, anesthesiology department	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	Microcirculation status	Microcirculation examination	120min	No