NCT03084978
Withdrawn
Not Applicable
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time
ConditionsAortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Montefiore Medical Center
- Primary Endpoint
- Time-on-table
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
- •Age over 18 years of age.
- •Women of child bearing age must have a negative urine or serum pregnancy test.
- •Clinical indication for a transfemoral aortic valve replacement.
- •English or Spanish speaking
- •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
- •Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr.
- •High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
- •Inability to lie supine for more than 30 minutes.
- •Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
- •Patient refusal
- •Patient involved in another research study
- •Psychiatric condition precluding ability to provide informed consent
- •History of clinical stroke within 3 months prior to randomization
Outcomes
Primary Outcomes
Time-on-table
Time Frame: <1 day
* time to patient on table to surgical drapes down * time to patient on table to when deemed safe for transport by anesthesiologist and surgeon
Secondary Outcomes
- Number of patients with serious adverse events(within 30 days)
- Length of stay(within 30 days)
- Readmissions(within 30 days)
- Number of Patients with Valve Complications(within 30 days)
- Contrast usage(<1 day)
- Fluoroscopy time(<1 day)
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