Conscious Sedation vs General Anesthesia in TAVR Patients

Study 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.

Official Title
-----------------
Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Procedure: General Anesthesia
* Procedure: Conscious Sedation


Participation Criteria
=================
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: BMI > 40 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General Anesthesia<br>Subjects will undergo general anesthesia with endotracheal intubation. | Procedure: General Anesthesia<br>* General anesthesia by standard endotracheal intubation.<br>|
| Experimental: Conscious Sedation<br>Subjects will undergo conscious sedation anesthesia. | Procedure: Conscious Sedation<br>* Conscious sedation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-on-table | time to patient on table to surgical drapes down time to patient on table to when deemed safe for transport by anesthesiologist and surgeon | <1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with serious adverse events | deaths conversion from sedation to intubation hypersensitivity reactions | within 30 days | 
| Length of stay | ICU length of stay (days) Hospital length of stay (days) | within 30 days | 
| Readmissions | Number of patients readmitted within 30 days of initial procedure | within 30 days | 
| Number of Patients with Valve Complications | paravalvular leak on echocardiogram pacemaker requirement vascular complications requiring reintervention post-procedure requiring valve dilation | within 30 days | 
| Contrast usage | Amount of contrast used in mL for procedure | <1 day | 
| Fluoroscopy time | Amount of time fluoroscopy used | <1 day |