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

Carilion Clinic

Status and phase

Invitation-only

Phase 4

Conditions

Orthopedic Disorder

Sports Injury

Anesthesia

Rotator Cuff Injuries

Rotator Cuff Tears

Treatments

Drug: TIVA with Propofol

Drug: Inhaled Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04793022

IRB19-471

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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