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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01179438
Collaborator
(none)
0
1
10
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2011
Anticipated Study Completion Date :
Jun 1, 2011

Outcome Measures

Primary Outcome Measures

  1. Microcirculation status [120min]

    Microcirculation examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital, anesthesiology department Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01179438
Other Study ID Numbers:
  • 201003036M
First Posted:
Aug 11, 2010
Last Update Posted:
Dec 10, 2012
Last Verified:
Jun 1, 2010
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2012