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

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.

Study Overview

• Status: Completed
• Conditions: Transesophageal Echocardiography
• Intervention / Treatment: Drug: local anesthesia; Behavioral: hypnosis; Drug: Midazolam

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul
    • Bakirkoy, Istanbul, Turkey, 34147
      • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 83 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a need of transesophageal echocardiography

Exclusion Criteria:

• Heart failure
• Bad overall condition
• Arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: topical pharyngeal anesthesia; There were 26 patients who had the procedure under topical pharyngeal anesthesia.	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
ACTIVE_COMPARATOR: midazolam; There were 25 patients who received midazolam.	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.
NO_INTERVENTION: hypnosis; There were 27 patients receiving hypnosis.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (ESTIMATE): October 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: age range of 18-83
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: yuksel-dogan-2011