The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murat Gonenc, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT01444976
First received: May 26, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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 Intervention
Transesophageal Echocardiography
Drug: local anesthesia
Behavioral: hypnosis
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bakirkoy Dr. Sadi Konuk Research and Training Hospital:

Primary Outcome Measures:
  • Hypnotic sedation [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 76
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 83 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a need of transesophageal echocardiography

Exclusion Criteria:

  • Heart failure
  • Bad overall condition
  • Arrhythmia
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 26, 2011
Last Updated: September 30, 2011
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 30, 2014