Rotator Cuff TearsPhase 4TIVANCT04793022
Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries
A Phase 4 study testing TIVA with Propofol and Inhaled Anesthesia in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Carilion Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Orthopedic Disorder
- What is being tested?
- TIVA with Propofol and Inhaled Anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 1 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Candidate for a shoulder arthroscopic procedure in the beach chair position
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Institute of Orthopedics and Neurosurgery
Roanoke, Virginia, 240176
About this study
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
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.
Read the 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.
- Being tested
- TIVA with Propofol, Inhaled Anesthesia
- Medical subject headings
- Rotator Cuff Injuries, Musculoskeletal Diseases, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVA with PropofolDrug
Also called Propofol
Total intravenous anesthesia with propofol
Inhaled AnesthesiaDrug
Also called General Anesthesia
General anesthesia given with inhaled anesthetics
| Study group | Role | What they receive |
|---|---|---|
| TIVA-Propofol | Experimental | Intravenous anesthesia with Propofol Receives: Drug: TIVA with Propofol |
| Inhaled Anesthesia | Active comparator | General Inhaled Anesthesia Receives: Drug: Inhaled Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to meet discharge criteria
How long it takes until the patient is ready to be discharged from the PACU
Measured: Immediately after the intervention/procedure/surgery
Secondary outcomes (6)
Pain Scale
Pain measured via pain scale: 0 through 5. 0 is no pain, 5 is worst pain ever felt.
Measured: 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
Measured: 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.
Measured: 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
Measured: Immediately after the intervention/procedure/surgery
Antiemetic use in PACU
Counting dosage of antiemetic use in PACU.
Measured: Immediately after the intervention/procedure/surgery
Surgical time
Time patient is in surgery.
Measured: During the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start2 Feb 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Tuttle, MD, MS, Principal investigator, Carilion Clinic Ortho Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793022
- Sponsor's protocol ID
- IRB19-471
- Acronym
- TIVA
- Status last verified
- Jan 2023
- First submitted
- 22 Feb 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected, de-identified, and published in a manuscript once the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04793022
- Acronym / sponsor ID
- TIVA / IRB19-471
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA-Propofol | Experimental | Drug: TIVA with PropofolIntravenous anesthesia with Propofol |
| Inhaled Anesthesia | Active comparator | Drug: Inhaled AnesthesiaGeneral Inhaled Anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-75 years of age
- Candidate for a shoulder arthroscopic procedure in the beach chair position
Key exclusion criteria (15 listed)
- American Society of Anesthesiologists (ASA) level 4 or above
- History of brachial plexus injury
- Chronic Obstructive Pulmonary Disorder
- Unstable Asthma
- BMI greater than 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIVA with PropofolAlso: PropofolTotal intravenous anesthesia with propofol | Drug | TIVA-Propofol |
| Inhaled AnesthesiaAlso: General AnesthesiaGeneral anesthesia given with inhaled anesthetics | Drug | Inhaled Anesthesia |
Primary outcome
Time to meet discharge criteria
Time frame: Immediately after the intervention/procedure/surgery
How long it takes until the patient is ready to be discharged from the PACU
6 secondary outcomes
Pain Scale
Time frame: Baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Number of procedures requiring anesthetic intervention during surgery
Time frame: During the intervention/procedure/surgery
Satisfaction scale
Time frame: Up to 21 days after procedure.
post-anaesthesia care unit (PACU) I to post-anaesthesia care unit (PACU) II transition time
Time frame: Immediately after the intervention/procedure/surgery
Antiemetic use in PACU
Time frame: Immediately after the intervention/procedure/surgery
Surgical time
Time frame: During the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No. Data will be collected, de-identified, and published in a manuscript once the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Tuttle, MD, MS principal investigator
Carilion Clinic Ortho Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TIVA with Propofol and Inhaled Anesthesia in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to meet discharge criteria (time frame: Immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.