Conscious Sedation vs General Anesthesia in TAVR Patients

Not Applicable

Withdrawn

• Conditions: Aortic Stenosis
• Interventions: Procedure: General Anesthesia; Procedure: Conscious Sedation

• Registration Number: NCT03084978
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-04
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia	General Anesthesia	Subjects will undergo general anesthesia with endotracheal intubation.
Conscious Sedation	Conscious Sedation	Subjects will undergo conscious sedation anesthesia.

Primary Outcome Measures

Name	Time	Method
Time-on-table	<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 Outcome Measures

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