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

NCT01179438 | Withdrawn Phase 4

• 1 other identifier: 201003036M
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microcirculation

Outcome Measures

Primary Outcomes (1)

• Microcirculation status

  Microcirculation examination

  120min

Interventions

Dexmedetomidine DRUG

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, anesthesiology department

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: August 11, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 10, 2012

Record last verified: 2010-06

Locations

TW (1)