The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Transesophageal Echocardiography

Intervention / Treatment
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* Drug: local anesthesia
* Behavioral: hypnosis
* Drug: Midazolam


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical pharyngeal anesthesia<br>There were 26 patients who had the procedure under topical pharyngeal anesthesia. | Drug: local anesthesia<br>* patients will receive only topical anesthesia with 1% lidocaine<br>Behavioral: hypnosis<br>* Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method<br>|
| Active Comparator: midazolam<br>There were 25 patients who received midazolam. | Behavioral: hypnosis<br>* Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method<br>Drug: Midazolam<br>* 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.<br>|
| No Intervention: hypnosis<br>There were 27 patients receiving hypnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age range of 18-83