Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study
|ClinicalTrials.gov Identifier: NCT01687868|
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : March 5, 2014
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 or disease||Intervention/treatment||Phase|
|Arthroscopic Shoulder Surgery in the Beach-chair Position||Drug: Dexmedetomidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|Experimental: dexmedetomidine continuous infusion||
dexmedetomidine 0.7mcg/kg/hr continuous infusion
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687868
|Korea, Republic of|
|Department of Anesthesiology and Pain Medicine,Yonsei University Health System|
|Seoul, Korea, Republic of, 120-752|