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

NCT ID: NCT04793022

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-02
• Study Completion Date: 2023-08-01

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries; Orthopedic Disorder; Sports Injury; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TIVA-Propofol

Intravenous anesthesia with Propofol

Group Type: EXPERIMENTAL

TIVA with Propofol

Intervention Type: DRUG

Total intravenous anesthesia with propofol

Inhaled Anesthesia

General Inhaled Anesthesia

Group Type: ACTIVE_COMPARATOR

Inhaled Anesthesia

Intervention Type: DRUG

General anesthesia given with inhaled anesthetics

Interventions

TIVA with Propofol

Total intravenous anesthesia with propofol

Intervention Type: DRUG

Inhaled Anesthesia

General anesthesia given with inhaled anesthetics

Intervention Type: DRUG

Other Intervention Names

Propofol; General Anesthesia

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Tuttle, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic Ortho Surgeon

Locations

Carilion Clinic Institute of Orthopedics and Neurosurgery

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

IRB19-471

Identifier Type: -

Identifier Source: org_study_id