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Total Intravenous Anesthesia With Propofol vs. General Anesthesia in Outpatient Shoulder Arthroscopic Surgeries (TIVA Trial)
Phase 4
Waitlist Available
Led By John Tuttle, MD, MS
Research Sponsored by Carilion Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the intervention/procedure/surgery
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial is testing a new anesthesia method for shoulder surgeries. Instead of inhaling anesthesia and using a breathing tube, patients receive Propofol through an IV and targeted pain relief. The goal is to help patients recover faster and have fewer side effects.
Eligible Conditions
- Rotator Cuff Injury
- Orthopedic Disorders
- Sports Injuries
- Rotator Cuff Tears
- Anesthesia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention/procedure/surgery, and up to 21 days after procedure.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to meet discharge criteria
Secondary study objectives
Antiemetic use in PACU
Number of procedures requiring anesthetic intervention during surgery
Pain Scale
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TIVA-PropofolExperimental Treatment1 Intervention
Intravenous anesthesia with Propofol
Group II: Inhaled AnesthesiaActive Control1 Intervention
General Inhaled Anesthesia
Find a Location
Who is running the clinical trial?
Carilion ClinicLead Sponsor
82 Previous Clinical Trials
15,181 Total Patients Enrolled
John Tuttle, MD, MSPrincipal InvestigatorCarilion Clinic Ortho Surgeon