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

Phase 4

• Conditions: Rotator Cuff Tears; Sports Injury; Orthopedic Disorder; Anesthesia; Rotator Cuff Injuries
• Interventions: Drug: Inhaled Anesthesia; Drug: TIVA with Propofol

• Registration Number: NCT04793022
• Lead Sponsor: Carilion Clinic

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.

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Anesthesia	Inhaled Anesthesia	General Inhaled Anesthesia
TIVA-Propofol	TIVA with Propofol	Intravenous anesthesia with Propofol

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Antiemetic use in PACU	Immediately after the intervention/procedure/surgery	Counting dosage of antiemetic use in PACU.
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.
Surgical time	During the intervention/procedure/surgery	Time patient is in surgery.
Number of procedures requiring anesthetic intervention during surgery	During the intervention/procedure/surgery	Use of preoperative interventions including vasopressors, antiemetics, sedatives
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.
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

Trial Locations

Locations (1)

Carilion Clinic Institute of Orthopedics and Neurosurgery; 🇺🇸 Roanoke, Virginia, United States