COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Hypnosis vs Midazolam for Sedation for TEE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749475
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : March 1, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Clinical Indications for Transesophageal Echocardiography Drug: Midazolam Other: hypnotherapy

Layout table for study information
Study Type : Observational
Actual Enrollment : 98 participants
Time Perspective: Prospective
Official Title: Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam
Study Start Date : June 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
midazolam Drug: Midazolam
The patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given.

hypnosis Other: hypnotherapy
A first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed.

Primary Outcome Measures :
  1. Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring [ Time Frame: during transesophageal echocardiography ]

Secondary Outcome Measures :
  1. measurement of alertness after sedation with continuous performance test (CPT) [ Time Frame: the same time frame ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients admitting to cardiology department for transesophageal echocardiography (TEE)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749475

Layout table for location information
Bakirkoy Dr Sadi Konuk Training Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Layout table for additonal information
Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital Identifier: NCT01749475    
Other Study ID Numbers: HYPTEE
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action