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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA-Propofol | Experimental | Intravenous anesthesia with Propofol |
|
| Inhaled Anesthesia | Active Comparator | General Inhaled Anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA with Propofol | Drug | Total intravenous anesthesia with propofol |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Tuttle, MD, MS | Carilion Clinic Ortho Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic Institute of Orthopedics and Neurosurgery | Roanoke | Virginia | 240176 | United States |
Data will be collected, de-identified, and published in a manuscript once the study is completed.
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| Inhaled Anesthesia | Drug | General anesthesia given with inhaled anesthetics |
|
|
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 |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D009140 | Musculoskeletal Diseases |
| D001265 | Athletic Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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