The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Bakirkoy Dr. Sadi Konuk Research and Training Hospital76 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transesophageal Echocardiography

Interventions

local anesthesiaDRUG

patients will receive only topical anesthesia with 1% lidocaine

hypnosisBEHAVIORAL

Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method

MidazolamDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 83 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a need of transesophageal echocardiography Exclusion Criteria: * Heart failure * Bad overall condition * Arrhythmia

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Bakırköy, Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Hypnotic sedation

Contrary to sedation with midazolam; when hypnosis is used for sedation in TEE patients, autonomic cardiac tone is modified to a significant extent. Hypnotic sedation achieves this by increasing the parasympathetic activity, decreasing the sympathetic activity and changing the sympathovagal interaction balance.

Time frame: two months

Data from ClinicalTrials.gov

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