The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

Transesophageal Echocardiography Clinical Trial

Official title:

The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444976
• Other study ID #: yuksel-dogan-2011
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: September 30, 2011
• Start date: December 2010
• Est. completion date: March 2011

Study information

• Verified date: September 2011
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 83 Years

Eligibility

Inclusion Criteria:

• Patients with a need of transesophageal echocardiography

Exclusion Criteria:

• Heart failure

• Bad overall condition

• Arrhythmia

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transesophageal Echocardiography

Intervention

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

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.

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr. Sadi Konuk Research and Training Hospital	Bakirkoy	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes