Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMarch 5, 2014
March 1, 2014
10 months
September 5, 2012
March 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Regional cerebral oxygen saturation value
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)
T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery
Study Arms (1)
dexmedetomidine continuous infusion
EXPERIMENTALInterventions
dexmedetomidine 0.7mcg/kg/hr continuous infusion
Eligibility Criteria
You may qualify if:
- ASA I-II
- Aged between 20 and 70 year
- general anesthesia for arthroscopic shoulder surgery in the beach-chair position
You may not qualify if:
- Congestive heart failure, coronary artery occlusive disease
- Bradycardia \< 50 BPM, 2nd degree \< AV block
- Poorly controlled hypertension
- ß blocker medication
- Coagulopathy
- Pregnancy, nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine,Yonsei University Health System
Seoul, Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 19, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
March 5, 2014
Record last verified: 2014-03