Conscious Sedation vs General Anesthesia in TAVR Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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General Anesthesia

Subjects will undergo general anesthesia with endotracheal intubation.

Group Type ACTIVE_COMPARATOR

General Anesthesia

Intervention Type PROCEDURE

General anesthesia by standard endotracheal intubation.

Conscious Sedation

Subjects will undergo conscious sedation anesthesia.

Group Type EXPERIMENTAL

Conscious Sedation

Intervention Type PROCEDURE

Conscious sedation

Interventions

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General Anesthesia

General anesthesia by standard endotracheal intubation.

Intervention Type PROCEDURE

Conscious Sedation

Conscious sedation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No