The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
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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 |
- 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 |
Inclusion Criteria:
- Patients with a need of transesophageal echocardiography
Exclusion Criteria:
- Heart failure
- Bad overall condition
- Arrhythmia
Contacts and Locations 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 Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013