Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries (TIVA)
Primary Purpose
Rotator Cuff Tears, Rotator Cuff Injuries, Orthopedic Disorder
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
TIVA with Propofol
Inhaled Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears
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
Sites / Locations
- Carilion Clinic Institute of Orthopedics and Neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TIVA-Propofol
Inhaled Anesthesia
Arm Description
Intravenous anesthesia with Propofol
General Inhaled Anesthesia
Outcomes
Primary Outcome Measures
Time to meet discharge criteria
How long it takes until the patient is ready to be discharged from the PACU
Secondary Outcome Measures
Pain Scale
Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt.
Number of procedures requiring anesthetic intervention during surgery
Use of preoperative interventions including vasopressors, antiemetics, sedatives
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.
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
Antiemetic use in PACU
Counting dosage of antiemetic use in PACU.
Surgical time
Time patient is in surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04793022
Brief Title
Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Rotator Cuff Injuries, Orthopedic Disorder, Sports Injury, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TIVA-Propofol
Arm Type
Experimental
Arm Description
Intravenous anesthesia with Propofol
Arm Title
Inhaled Anesthesia
Arm Type
Active Comparator
Arm Description
General Inhaled Anesthesia
Intervention Type
Drug
Intervention Name(s)
TIVA with Propofol
Other Intervention Name(s)
Propofol
Intervention Description
Total intravenous anesthesia with propofol
Intervention Type
Drug
Intervention Name(s)
Inhaled Anesthesia
Other Intervention Name(s)
General Anesthesia
Intervention Description
General anesthesia given with inhaled anesthetics
Primary Outcome Measure Information:
Title
Time to meet discharge criteria
Description
How long it takes until the patient is ready to be discharged from the PACU
Time Frame
Immediately after the intervention/procedure/surgery
Secondary Outcome Measure Information:
Title
Pain Scale
Description
Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt.
Time Frame
Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Title
Number of procedures requiring anesthetic intervention during surgery
Description
Use of preoperative interventions including vasopressors, antiemetics, sedatives
Time Frame
During the intervention/procedure/surgery
Title
Satisfaction scale
Description
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.
Time Frame
Up to 21 days after procedure.
Title
post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time
Description
The amount of time it takes to go from PACU I to PACU II
Time Frame
Immediately after the intervention/procedure/surgery
Title
Antiemetic use in PACU
Description
Counting dosage of antiemetic use in PACU.
Time Frame
Immediately after the intervention/procedure/surgery
Title
Surgical time
Description
Time patient is in surgery.
Time Frame
During the intervention/procedure/surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Tuttle, MD, MS
Organizational Affiliation
Carilion Clinic Ortho Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Clinic Institute of Orthopedics and Neurosurgery
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
240176
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be collected, de-identified, and published in a manuscript once the study is completed.
Learn more about this trial
Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries
We'll reach out to this number within 24 hrs