Hypnosis vs Midazolam for Sedation for TEE

Completed

• Conditions: Clinical Indications for Transesophageal Echocardiography
• Interventions: Other: hypnotherapy; Drug: Midazolam

• Registration Number: NCT01749475
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

Most of the reports on hypnosis in the literature have focused on pain control during minor operations. With this study we aimed to evaluate the role of hypnosis on sedation for transesophageal echocardiography and compare it with commonly used sedative midazolam.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• indications for TEE
• American Society of Anesthesiology (ASA) physical status I-III

Exclusion Criteria

• mental illness,
• psychotropic medication use,
• hypersensitivity to drugs
• a body mass index over 30.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hypnosis	hypnotherapy	-
midazolam	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring	during transesophageal echocardiography

Secondary Outcome Measures

Name	Time	Method
measurement of alertness after sedation with continuous performance test (CPT)	the same time frame

Trial Locations

Locations (1)

Bakirkoy Dr Sadi Konuk Training Hospital; 🇹🇷 Istanbul, Turkey