Brief Title
Conscious Sedation vs General Anesthesia in TAVR Patients
Official Title
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
Brief Summary
This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
Study Type
Interventional
Primary Outcome
Time-on-table
Secondary Outcome
Number of patients with serious adverse events
Condition
Aortic Stenosis
Intervention
General Anesthesia
Study Arms / Comparison Groups
General Anesthesia
Description: Subjects will undergo general anesthesia with endotracheal intubation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
April 2017
Completion Date
April 2019
Primary Completion Date
April 2019
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation) 2. Age over 18 years of age. 3. Women of child bearing age must have a negative urine or serum pregnancy test. 4. Clinical indication for a transfemoral aortic valve replacement. 5. English or Spanish speaking 6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization. Exclusion Criteria: 1. BMI > 40 2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr. 3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc). 4. Inability to lie supine for more than 30 minutes. 5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access. 6. Patient refusal 7. Patient involved in another research study 8. Psychiatric condition precluding ability to provide informed consent 9. History of clinical stroke within 3 months prior to randomization
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Joseph DeRose, MD, ,
Administrative Informations
NCT ID
NCT03084978
Organization ID
2016-7021
Responsible Party
Sponsor
Study Sponsor
Montefiore Medical Center
Study Sponsor
Joseph DeRose, MD, Principal Investigator, Montefiore Medical Center
Verification Date
June 2019