Anesthesia, Orthopedic Disorder, Rotator Cuff Injuries, Rotator Cuff Tears, Sports Injury
Conditions
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.
Interventions
DRUGTIVA with Propofol
Total intravenous anesthesia with propofol
DRUGInhaled Anesthesia
General anesthesia given with inhaled anesthetics
Sponsors
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to meet discharge criteria | Immediately after the intervention/procedure/surgery | How long it takes until the patient is ready to be discharged from the PACU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of procedures requiring anesthetic intervention during surgery | During the intervention/procedure/surgery | Use of preoperative interventions including vasopressors, antiemetics, sedatives |
| Satisfaction scale | Up to 21 days after procedure. | 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. |
| Pain Scale | Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure. | Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt. |
| Antiemetic use in PACU | Immediately after the intervention/procedure/surgery | Counting dosage of antiemetic use in PACU. |
| Surgical time | During the intervention/procedure/surgery | Time patient is in surgery. |
| post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time | Immediately after the intervention/procedure/surgery | The amount of time it takes to go from PACU I to PACU II |
Countries
United States
Outcome results
None listed