The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Transesophageal Echocardiography

Treatments: Drug: local anesthesia; Drug: Midazolam; Behavioral: hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01444976

yuksel-dogan-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 83 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a need of transesophageal echocardiography

Exclusion criteria

• Heart failure
• Bad overall condition
• Arrhythmia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

topical pharyngeal anesthesia

Active Comparator group

Description:

There were 26 patients who had the procedure under topical pharyngeal anesthesia.

Treatment:

Behavioral: hypnosis

Drug: local anesthesia

midazolam

Active Comparator group

Description:

There were 25 patients who received midazolam.

Treatment:

Behavioral: hypnosis

Drug: Midazolam

hypnosis

No Intervention group

Description:

There were 27 patients receiving hypnosis.