Monitored Anesthesia Care vs. General Anesthesia for Transcatheter Aortic Valve Replacement

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Sep 25, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different types of anesthesia—monitored anesthetic care (MAC) and general anesthesia (GETA)—on patients undergoing a procedure called Transcatheter Aortic Valve Replacement (TAVR). The researchers want to see how these two anesthesia methods affect how long patients stay in the hospital, whether they need to go to the intensive care unit (ICU), and the safety of the procedure. They are also looking at whether using a special imaging technique called Transesophageal Echocardiography (TEE) during general anesthesia makes the procedure more successful.

To participate in this study, you need to be an adult (18 years or older) who is having a TAVR procedure through the femoral artery for a condition called aortic valve stenosis. However, there are some important factors that may prevent you from taking part. For example, if you have certain medical issues or can't lie flat, or if you are pregnant, you won't be eligible. If you join the trial, you can expect close monitoring during your procedure and support from the medical team to ensure your safety and comfort. This research aims to help improve care for patients like you in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients ≥ 18 years old
• • Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis
• • Adult patients who are medically eligible to receive both anesthetics (GA and MAC)
• Exclusion Criteria:
• • Inability to speak English
• • Body Mass Index (BMI) \> 37 kg/m2
• • History of difficult airway requiring fiberoptic intubation
• • Inability to lie flat
• • Women who are pregnant
• • Patients who have contraindications to either anesthetic, such as an allergy or history of malignant hyperthermia, will also be excluded from the study.
• • Inability or unwillingness of subject to give informed consent based on any reason
• * Patients with any of the following absolute contraindications to TEE:
• • Perforated Viscus
• • Esophageal Stricture
• • Esophageal Tumor
• • Esophageal Perforation
• • Esophageal Diverticulum
• • Active upper GI Bleed