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The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

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ClinicalTrials.gov Identifier: NCT01444976
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Sponsor:
Information provided by (Responsible Party):
Murat Gonenc, 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.

Condition or disease Intervention/treatment
Transesophageal Echocardiography 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  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation
Study Start Date : December 2010
Primary Completion Date : February 2011
Study Completion Date : March 2011

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U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Hypnotic sedation [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 83 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a need of transesophageal echocardiography

Exclusion Criteria:

  • Heart failure
  • Bad overall condition
  • Arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444976


Locations
Turkey
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakirkoy, Istanbul, Turkey, 34147
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Responsible Party: Murat Gonenc, Cardiology Clinic, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01444976     History of Changes
Other Study ID Numbers: yuksel-dogan-2011
First Posted: October 3, 2011    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Keywords provided by Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital:
age range of 18-83

Additional relevant MeSH terms:
Anesthetics
Midazolam
Central Nervous System Depressants
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action