Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Study Overview
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Brief Summary
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Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine lateral position for spinal anesthesia in femur proximal fracture patients

Detailed Description
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Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading. After 10 minutes of drug infusion, patients are prepared for spinal anesthesia. pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection) When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject. Patients will be injected propofol 10mg when they have agitation signs during operation. vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection

Official Title
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Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients

Conditions
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Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Fentanyl
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of anesthesiologists classification 1-3 patients >20 years old Exclusion Criteria: patients refuse dementia patients, cooperation difficult patients anaphylaxis of dexmedetomidine, ketamine, local anesthetics heart problem (bradycardia, atrioventricular block)

Ages Eligible for Study
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Minimum Age: 20 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine-ketamine<br>Dexmedetomidine-ketamine group | Drug: Dexmedetomidine<br>* dexmedetomidine infusion during spinal anesthesia<br>* Other names: Precedex;Drug: Ketamine<br>* add dexmedetomidine during position change<br>* Other names: ketamine HCl;|
| Active Comparator: Dexmedetomidine-fentanyl<br>Dexmedetomidine-fentanyl group | Drug: Dexmedetomidine<br>* dexmedetomidine infusion during spinal anesthesia<br>* Other names: Precedex;Drug: Fentanyl<br>* add dexmedetomidine during position change<br>* Other names: fentanyl citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Using Five Scales | We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia. | average 10-20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Patient Positioning | We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups. | average 10-20 minutes during spinal anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Ketamine, Pain