Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block

Study Overview
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Brief Summary
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The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study. Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Detailed Description
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The anesthesia provided during shoulder surgery commonly uses a combination of regional and intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use of it problematic in cases where the head of the patient is less accessible to the anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved drug, which has a very stable cardiovascular and respiratory profile. It has been successfully used for Neurological and Vascular cases and in Intensive care units. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this study. Using a computer program the participants will be randomized into two equal groups to receive either Dexmedetomidine or Propofol. The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol. Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0 mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained with Propofol at 50-120mcg/kg/min, during the surgery. In each group the investigators will record the incidence of respiratory depression/hypoxia, hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge time, the need for postoperative pain medication, post operative complications, like nausea/vomiting. Significant differences between the two groups will be evaluated using unpaired t-test for numerical variables, and Chi-square test or Z test for categorical variables. The investigators hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Official Title
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Dexmedetomidine vs Propofol TIVA and Interscalene Block for Shoulder Surgeries in a Beach Chair Sitting Position

Conditions
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Shoulder Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol
* Other: Interscalene block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants scheduled for shoulder arthroscopies in the beach chair sitting position. Participants who received a successful interscalene block. Exclusion Criteria: Failed interscalene block. Refusal to participate in the study. Allergy to the study drugs. Participants that need a secure airway.

Ages Eligible for Study
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Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>Participants will receive an interscalene block and be sedated with dexmedetomidine | Drug: Dexmedetomidine<br>* Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol<br>* Other names: precedex;Other: Interscalene block<br>* Interscalene block is used for the main anesthetic for the case<br>|
| Active Comparator: Propofol<br>Participants will receive an interscalene block and be sedated with propofol | Drug: Propofol<br>* Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine<br>* Other names: diprivan;Other: Interscalene block<br>* Interscalene block is used for the main anesthetic for the case<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Need an Airway Intervention. | airway manipulation or repositioning: apnea, oral airway, adjust head | Participants will be followed from the start of sedation until discharge: approximately 3-5 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Anesthesia Care Unit (PACU) Length of Stay | length of stay in minutes in the Post Anesthesia Care Unit before discharge | Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation | 
| Number of Participants That Have Either Bradycardia or Hypotension | Number of participants observed with Bradycardia or Hypotension who required intervention | Participants will be followed from the start of sedation until discharge: approximately 3-5 hr | 
| Total Narcotic Used by Each Participant | the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents | Participants will be followed from the start of sedation until discharge: approximately 3-5 hr |