Conscious Sedation vs General Anesthesia in TAVR Patients

Overview

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.

Full Title of Study: “Randomized Prospective Study in Transcatheter Aortic Valve Replacement Patients- Conscious Sedation VS. General Anesthesia Examining the Effect on Operative Time”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 2019

Interventions

  • Procedure: General Anesthesia
    • General anesthesia by standard endotracheal intubation.
  • Procedure: Conscious Sedation
    • Conscious sedation

Arms, Groups and Cohorts

  • Active Comparator: General Anesthesia
    • Subjects will undergo general anesthesia with endotracheal intubation.
  • Experimental: Conscious Sedation
    • Subjects will undergo conscious sedation anesthesia.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Montefiore Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph DeRose, MD, Principal Investigator, Montefiore Medical Center

References

Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.