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The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

NCT ID: NCT01444976

Last Updated: 2011-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Transesophageal Echocardiography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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topical pharyngeal anesthesia

There were 26 patients who had the procedure under topical pharyngeal anesthesia.

Group Type ACTIVE_COMPARATOR

local anesthesia

Intervention Type DRUG

patients will receive only topical anesthesia with 1% lidocaine

hypnosis

Intervention Type BEHAVIORAL

Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method

midazolam

There were 25 patients who received midazolam.

Group Type ACTIVE_COMPARATOR

hypnosis

Intervention Type BEHAVIORAL

Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method

Midazolam

Intervention Type 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.

hypnosis

There were 27 patients receiving hypnosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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local anesthesia

patients will receive only topical anesthesia with 1% lidocaine

Intervention Type DRUG

hypnosis

Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method

Intervention Type BEHAVIORAL

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with a need of transesophageal echocardiography

Exclusion Criteria

* Heart failure
* Bad overall condition
* Arrhythmia
Minimum Eligible Age

18 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Murat Gonenc

Cardiology Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Bakırköy, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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yuksel-dogan-2011

Identifier Type: -

Identifier Source: org_study_id