The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
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.
Drug: local anesthesia
|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.
|Study Start Date:||December 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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% lidocaineBehavioral: 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.
Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's methodDrug: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444976
|Bakirkoy Dr. Sadi Konuk Research and Training Hospital|
|Bakirkoy, Istanbul, Turkey, 34147|