Clinical trial NCT04793022: Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Orthopedic Disorder
Sports Injury
Anesthesia
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to meet discharge criteria
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Pain Scale
timeFrame: Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
measure: Number of procedures requiring anesthetic intervention during surgery
timeFrame: During the intervention/procedure/surgery
measure: Satisfaction scale
timeFrame: Up to 21 days after procedure.
measure: post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time
timeFrame: Immediately after the intervention/procedure/surgery
measure: Antiemetic use in PACU
timeFrame: Immediately after the intervention/procedure/surgery
measure: Surgical time
timeFrame: During the intervention/procedure/surgery
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic Institute of Orthopedics and Neurosurgery
state: Virginia
Study officials:
affiliation: Carilion Clinic Ortho Surgeon
name: John Tuttle, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: