The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability
|ClinicalTrials.gov Identifier: NCT01444976|
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : October 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Transesophageal Echocardiography||Drug: local anesthesia Behavioral: hypnosis Drug: Midazolam||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||March 2011|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444976
|Bakirkoy Dr. Sadi Konuk Research and Training Hospital|
|Bakirkoy, Istanbul, Turkey, 34147|