Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries

Study Overview
=================
Brief Summary
-----------------
This study is comparing total intravenous anesthesia with propofol with a regional nerve block against general anesthesia with a regional nerve block on the primary endpoint of time to meet discharge criteria.

Detailed Description
-----------------
The primary objective of this study is to determine if using Total Intravenous Anesthesia with Propofol (TIVA-P sedation) with a regional nerve block will decrease the time to meet discharge criteria. This will be done with patients undergoing shoulder arthroscopic procedures at the Roanoke Ambulatory Surgical Center. Currently, inhaled general anesthesia (GA) with a regional nerve block is utilized for these outpatient arthroscopic procedures. This involves the patient receiving Propofol through an IV to put a patient to sleep, followed by intubation (breathing tube in throat) and the administration of inhaled anesthesia for the duration of the procedure. Another approach for anesthesia in these procedures is TIVA-P sedation. In this protocol the patient receives the same initial amount of Propofol through the IV as they would if they were getting general anesthesia. Once they are asleep, it is maintained with a continuous intravenous administration of Propofol. With this approach, the patient is not intubated and exposed to the same anesthetic agents as general anesthesia. As a result, the patient may not experience the potential side effects associated with general anesthesia. We believe that this will lead to a faster time to meet discharge criteria and also fewer of anesthetic side effects.

Official Title
-----------------
A Prospective Clinical Trial Comparing General Anesthesia With Interscalene Nerve Block vs. Deep Sedation Via TIVA-P With Interscalene Nerve Block in Outpatient Shoulder Arthroscopies

Conditions
-----------------
Rotator Cuff Tears, Rotator Cuff Injuries, Orthopedic Disorder, Sports Injury, Anesthesia

Intervention / Treatment
-----------------
* Drug: TIVA with Propofol
* Drug: Inhaled Anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years of age Candidate for a shoulder arthroscopic procedure in the beach chair position Exclusion Criteria: American Society of Anesthesiologists (ASA) level 4 or above History of brachial plexus injury Chronic Obstructive Pulmonary Disorder Unstable Asthma BMI greater than 40 Allergy to local anesthesic (bupivacaine) Contralateral phrenic nerve impairment History of Difficult Airway Poorly Controlled Gastroesophageal Reflux Disease Known Aspiration Risk Surgery not performed at the Roanoke Ambulatory Surgical Center Pregnant patients or patients who have a positive pre-operative human chorionic gonadotropin (beta-HCG) pregnancy test Coagulopathies Allergy to propofol Patient request for specific anesthesia method

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVA-Propofol<br>Intravenous anesthesia with Propofol | Drug: TIVA with Propofol<br>* Total intravenous anesthesia with propofol<br>* Other names: Propofol;|
| Active Comparator: Inhaled Anesthesia<br>General Inhaled Anesthesia | Drug: Inhaled Anesthesia<br>* General anesthesia given with inhaled anesthetics<br>* Other names: General Anesthesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meet discharge criteria | How long it takes until the patient is ready to be discharged from the PACU | Immediately after the intervention/procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scale | Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt. | Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure. | 
| Number of procedures requiring anesthetic intervention during surgery | Use of preoperative interventions including vasopressors, antiemetics, sedatives | During the intervention/procedure/surgery | 
| Satisfaction scale | How satisfied the patient is with their treatment, scale is rated 1-Poor, 2-Average, 3-Good, 4-Excellent with higher numbers equating to more patient satisfaction. | Up to 21 days after procedure. | 
| post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time | The amount of time it takes to go from PACU I to PACU II | Immediately after the intervention/procedure/surgery | 
| Antiemetic use in PACU | Counting dosage of antiemetic use in PACU. | Immediately after the intervention/procedure/surgery | 
| Surgical time | Time patient is in surgery. | During the intervention/procedure/surgery |