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Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687868
First Posted: September 19, 2012
Last Update Posted: March 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose

Patients undergoing shoulder arthroscopy in the beach chair position may be at risk for adverse neurologic events due to cerebral ischemia.

Dexmedetomidine, a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response in the perioperative period.

dexmedetomidine has an effect of peripheral vasoconstriction thus it is theologically appropriate for reducing bleeding for arthroscopic operation field.

The aim of this study is to evaluate the efficacy and the safety of dexmedetomidine on cerebral oxygen saturation, cognitive function, hemodynamic stability and operative field in patients undergoing arthroscopic shoulder surgery in the beach-chair position.


Condition Intervention
Arthroscopic Shoulder Surgery in the Beach-chair Position Drug: Dexmedetomidine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Regional cerebral oxygen saturation value [ Time Frame: T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery ]
    Before the anesthetic induction(T1), Before endotracheal intubation(T2), After endotracheal intubation(T3), Before the beach-chair position(T4), 5 minutes after the beach-chair position(T5), Before the operation(T6), 5 minutes after the incision(T7), After removal of the arthroscopy(T8), at the end of the operation(T9)


Enrollment: 19
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexmedetomidine continuous infusion Drug: Dexmedetomidine
dexmedetomidine 0.7mcg/kg/hr continuous infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • Aged between 20 and 70 year
  • general anesthesia for arthroscopic shoulder surgery in the beach-chair position

Exclusion Criteria:

  • Congestive heart failure, coronary artery occlusive disease
  • Bradycardia < 50 BPM, 2nd degree < AV block
  • Poorly controlled hypertension
  • ß blocker medication
  • Coagulopathy
  • Pregnancy, nursing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687868


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine,Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01687868     History of Changes
Other Study ID Numbers: 4-2012-0351
First Submitted: September 5, 2012
First Posted: September 19, 2012
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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