Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical pharyngeal anesthesia | Active Comparator | There were 26 patients who had the procedure under topical pharyngeal anesthesia. |
|
| midazolam | Active Comparator | There were 25 patients who received midazolam. |
|
| hypnosis | No Intervention | There were 27 patients receiving hypnosis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| local anesthesia | Drug | patients will receive only topical anesthesia with 1% lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypnotic sedation | 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. | two months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Bakırköy | Istanbul | 34147 | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D006990 | Hypnosis |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D026441 | Mind-Body Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hypnosis | Behavioral | Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method |
|
| Midazolam | Drug | 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. |
|
| D000529 |
| Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |