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

NCT04793022 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: IRB19-471
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to meet discharge criteria

  How long it takes until the patient is ready to be discharged from the PACU

  Immediately after the intervention/procedure/surgery

Secondary Outcomes (6)

• Pain Scale

  Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.

• Number of procedures requiring anesthetic intervention during surgery

  During the intervention/procedure/surgery

• Satisfaction scale

  Up to 21 days after procedure.

• post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time

  Immediately after the intervention/procedure/surgery

• Antiemetic use in PACU

  Immediately after the intervention/procedure/surgery

Study Arms (2)

TIVA-Propofol

EXPERIMENTAL

Intravenous anesthesia with Propofol

Drug: TIVA with Propofol

Inhaled Anesthesia

ACTIVE COMPARATOR

General Inhaled Anesthesia

Drug: Inhaled Anesthesia

Interventions

TIVA with Propofol DRUG

Total intravenous anesthesia with propofol

Also known as: Propofol

TIVA-Propofol

Inhaled Anesthesia DRUG

General anesthesia given with inhaled anesthetics

Also known as: General Anesthesia

Inhaled Anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Candidate for a shoulder arthroscopic procedure in the beach chair position

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic Institute of Orthopedics and Neurosurgery

Roanoke, Virginia, 240176, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Musculoskeletal Diseases; Athletic Injuries

Interventions

Propofol; Anesthesia, General

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia; Anesthesia and Analgesia

Study Officials

• John Tuttle, MD, MS

  Carilion Clinic Ortho Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 11, 2021
• Study Start: February 2, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)