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Hypnosis vs Midazolam for Sedation for TEE

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ClinicalTrials.gov Identifier: NCT01749475
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : March 1, 2013
Sponsor:
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

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

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U.S. FDA Resources

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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (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)
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01749475


Locations
Turkey
Bakirkoy Dr Sadi Konuk Training Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT01749475     History of Changes
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:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action