The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Not Applicable

Completed

• Conditions: Transesophageal Echocardiography
• Interventions: Drug: local anesthesia; Behavioral: hypnosis; Drug: Midazolam

• Registration Number: NCT01444976
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief 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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Study First Submitted: 2011-05-26
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-30
• Last Update Submitted: 2011-09-30
• Study First Posted: 2011-10-03
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Patients with a need of transesophageal echocardiography

Exclusion Criteria

• Heart failure
• Bad overall condition
• Arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical pharyngeal anesthesia	local anesthesia	There were 26 patients who had the procedure under topical pharyngeal anesthesia.
topical pharyngeal anesthesia	hypnosis	There were 26 patients who had the procedure under topical pharyngeal anesthesia.
midazolam	hypnosis	There were 25 patients who received midazolam.
midazolam	Midazolam	There were 25 patients who received midazolam.

Primary Outcome Measures

Name	Time	Method
Hypnotic sedation	two months	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.

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Bakirkoy, Istanbul, Turkey