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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01179438
First received: August 9, 2010
Last updated: December 6, 2012
Last verified: June 2010
  Purpose

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 Intervention Phase
Microcirculation
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effect of Dexmedetomidine on Microcirculation in Patients Undergoing Extracorporeal Shock Wave Lithotripsy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Microcirculation status [ Time Frame: 120min ] [ Designated as safety issue: No ]
    Microcirculation examination


Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179438

Locations
Taiwan
National Taiwan University Hospital, anesthesiology department
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yu-Chang Yeh, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01179438     History of Changes
Other Study ID Numbers: 201003036M
Study First Received: August 9, 2010
Last Updated: December 6, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014