NCT01444976

The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Other Government
• Sex: All
• Age: 18 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Transesophageal Echocardiography

Interventions

Type	Name	Description
DRUG	local anesthesia	patients will receive only topical anesthesia with 1% lidocaine
BEHAVIORAL	hypnosis	Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method
DRUG	Midazolam	Before insertion of the probe, the patients will be sedated with midazolam at a dose of 0,.05 mg/kg iv (to achieve a Ramsay Sedation Score of 2-3). If needed, additional iv doses (0.005 mg/kg) were given during the procedure.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2011-10-03
• Last updated: 2011-10-03

Locations

1 site across 1 country: Turkey (Türkiye)