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

Not Applicable

Completed

• Conditions: Arthroscopic Shoulder Surgery in the Beach-chair Position
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT01687868
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-19
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dexmedetomidine continuous infusion	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Regional cerebral oxygen saturation value	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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine,Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of