- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687868
Evaluation of Efficacy and Safety of General Anesthesia Using Dexmedetomidine With Sevoflurane in Patients Undergoing Arthroscopic Shoulder Surgery: Preliminary Study
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Department of Anesthesiology and Pain Medicine,Yonsei University Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dexmedetomidine continuous infusion
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dexmedetomidine 0.7mcg/kg/hr continuous infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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T1,T2,T3, T4, T5,T6, T7, T8, T9 time of post-dose during surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- 4-2012-0351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroscopic Shoulder Surgery in the Beach-chair Position
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Larissa University HospitalCompletedShoulder Surgery | Autonomic Nervous System | Interscalene Block | HRV | Beach Chair PositionGreece
-
Larissa University HospitalUnknownBradycardia | Hypotension | Shoulder Surgery | Autonomic Nervous System | Interscalene Block | Beach Chair PositionGreece
-
Loyola UniversityCompletedObese | Beach Chair Position | Shoulder Arthoscopy | Cerebral Desaturation EventsUnited States
-
Eric AlbrechtCompletedArthroscopic Surgery of the Shoulder | Extrafascial Interscalene Plexus Brachial BlockSwitzerland
Clinical Trials on Dexmedetomidine
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Cairo UniversityUnknownSpinal Anesthesia DurationEgypt
-
Guangzhou Women and Children's Medical CenterCompletedAmbulatory Surgical ProceduresChina
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The First Affiliated Hospital with Nanjing Medical...CompletedPostoperative Pain | Breast Feeding | Analgesia ObstetricalChina
-
Seoul National University Bundang HospitalCompleted
-
Guangzhou General Hospital of Guangzhou Military...CompletedPharmacodynamic InteractionChina
-
University Hospital DubravaRecruitingAortic Valve Stenosis | Systemic Inflammatory ResponseCroatia
-
Guangzhou General Hospital of Guangzhou Military...Completed
-
First Affiliated Hospital, Sun Yat-Sen UniversityUnknownArteriovenous MalformationChina
-
Guangzhou General Hospital of Guangzhou Military...UnknownCombined Spinal-epidural AnesthesiaChina
-
Eye & ENT Hospital of Fudan UniversityCompletedAgitated; State, Acute Reaction to StressChina