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

Anesthesia Clinical Trial

— TIVA  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04793022
• Other study ID #: IRB19-471
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: February 2, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2023
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 192
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Athletic Injuries
• Musculoskeletal Diseases
• Orthopedic Disorder
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Sports Injury
• Wounds and Injuries

Intervention

Drug:
• TIVA with Propofol
Total intravenous anesthesia with propofol
• Inhaled Anesthesia
General anesthesia given with inhaled anesthetics

Locations

Country	Name	City	State
United States	Carilion Clinic Institute of Orthopedics and Neurosurgery	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Scale	Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt.	Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Secondary	Number of procedures requiring anesthetic intervention during surgery	Use of preoperative interventions including vasopressors, antiemetics, sedatives	During the intervention/procedure/surgery
Secondary	Satisfaction scale	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.	Up to 21 days after procedure.
Secondary	post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time	The amount of time it takes to go from PACU I to PACU II	Immediately after the intervention/procedure/surgery
Secondary	Antiemetic use in PACU	Counting dosage of antiemetic use in PACU.	Immediately after the intervention/procedure/surgery
Secondary	Surgical time	Time patient is in surgery.	During the intervention/procedure/surgery