The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability

NCT01444976 | Completed

• 1 other identifier: yuksel-dogan-2011
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transesophageal Echocardiography

Keywords

age range of 18-83

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

topical pharyngeal anesthesia

ACTIVE COMPARATOR

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

Drug: local anesthesia; Behavioral: hypnosis

midazolam

ACTIVE COMPARATOR

There were 25 patients who received midazolam.

Behavioral: hypnosis; Drug: Midazolam

hypnosis

NO INTERVENTION

There were 27 patients receiving hypnosis.

Interventions

local anesthesia DRUG

patients will receive only topical anesthesia with 1% lidocaine

topical pharyngeal anesthesia

hypnosis BEHAVIORAL

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

midazolam; topical pharyngeal anesthesia

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.

midazolam

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a need of transesophageal echocardiography

You may not qualify if:

• Heart failure
• Bad overall condition
• Arrhythmia

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Bakırköy, Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Anesthesia, Local; Hypnosis; Midazolam

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Clinic

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: October 3, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

TU (1)