A Phase 4 interventional study of TIVA with Propofol and Inhaled Anesthesia in Rotator Cuff Tears, Rotator Cuff Injuries and Orthopedic Disorder, sponsored by Carilion Clinic. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Carilion Clinic · Phase 4, Interventional, and Treatment
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's planned enrollment of 192 is above the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Carilion Clinic is the lead sponsor of 71 studies on the registry; 13 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 2 (22%) have results posted.
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Exclusion Criteria:
Intravenous anesthesia with Propofol
Drug: TIVA with Propofol
General Inhaled Anesthesia
Drug: Inhaled Anesthesia
Total intravenous anesthesia with propofol
Also known as: Propofol
General anesthesia given with inhaled anesthetics
Also known as: General Anesthesia
Time to meet discharge criteria
How long it takes until the patient is ready to be discharged from the PACU
Time frame: Immediately after the intervention/procedure/surgery
Pain Scale
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.
Number of procedures requiring anesthetic intervention during surgery
Use of preoperative interventions including vasopressors, antiemetics, sedatives
Time frame: During the intervention/procedure/surgery
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.
Time frame: Up to 21 days after procedure.
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
Time frame: Immediately after the intervention/procedure/surgery
Antiemetic use in PACU
Counting dosage of antiemetic use in PACU.
Time frame: Immediately after the intervention/procedure/surgery
Surgical time
Time patient is in surgery.
Time frame: During the intervention/procedure/surgery
Plan to share: No — Data will be collected, de-identified, and published in a manuscript once the study is completed.
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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