The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Transesophageal Echocardiography Clinical Trial

Official title: The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation

Status Completed

Clinical Trial Summary

There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.

Clinical Trial Description

Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transesophageal Echocardiography

• NCT number: NCT01444976
• Study type: Interventional
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Completion date: March 2011