Dexmedetomidine in Spinal Anesthesia

Study Overview
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Brief Summary
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Patients were randomized into two groups, A group and B group. A group and B group patients are injected intravenous dexmedetomidine after intrathecal injection (IT) of heavy bupivacaine and injected intravenous dexmedetomidine before IT of heavy bupivacaine, respectively. The investigators will compare of hemodynamics and patient's comfortability between two groups.

Detailed Description
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A and B group patients will intravenous inject dexmedetomidine 1mcg/kg for 10 minute loading infusion and 0.2mcg/kg/hr for continuous infusion. A group receive intravenous dexmedetomidine after procedure, and B group receive intravenous dexmedetomidine before procedure. Both group patients will hydrate 6 ml/kg crystalloid solution and will evaluated patient's anxiety and comfortability perioperative period. Vital signs will record 5 minutes interval at operating room and post-anesthetic care units.

Official Title
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Hemodynamic Effect of Dexmedetomidine on Heavy Bupivacaine Spinal Anesthesia

Conditions
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Blood Pressure, Anxiety

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Dexmedetomidine with heavy bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 - 60 aged patients orthopedic operation undergoing spinal anesthesia Exclusion Criteria: more than American society of anesthesiologists classification 3 hypertension diabetes mellitus heart disease (bradycardia, atrioventricular block)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine | Drug: Dexmedetomidine<br>* Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine<br>* Other names: Precedex;|
| Active Comparator: Dexmedetomidine with heavy bupivacaine<br>IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine | Drug: Dexmedetomidine with heavy bupivacaine<br>* Dexmedetomidine infusion after IT of heavy bupivacaine<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypotension | We compare incidence rate of hypotension during infusion of dexmedetomidine | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Anxiety | We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery. | up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Spinal anesthesia