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WithdrawnNCT01179438Updated Dec 10, 2012

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

A Phase 4 interventional study of Dexmedetomidine in Microcirculation, sponsored by National Taiwan University Hospital. Withdrawn at 1 site in Taiwan. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-10.

Sponsored by National Taiwan University Hospital · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Microcirculation
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DrugDexmedetomidine

    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.

06

What researchers measure

Primary outcomes

  1. Microcirculation status

    Microcirculation examination

    Time frame: 120min

07

Study locations

1 site
  • National Taiwan University Hospital, anesthesiology department
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01179438
Lead sponsor
National Taiwan University Hospital
First posted
Aug 11, 2010
Start date
Aug 2010
Primary completion
Jun 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Dec 10, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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