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Clinical Trials/NCT01687868
NCT01687868CompletedNot Applicable

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

Yonsei University1 site in 1 country19 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
19
Locations
1
Primary Endpoint
Regional cerebral oxygen saturation value

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Arms & Interventions

dexmedetomidine continuous infusion

Experimental

Intervention: Dexmedetomidine (Drug)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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