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OpenTrials
Completed

NCT Number: NCT01749475

Hypnosis vs Midazolam for Sedation for TEE

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.

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Key information

Conditions

Clinical Indications for Transesophageal Echocardiography

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakirkoy Dr Sadi Konuk Training Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

midazolam

Drug

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.

Hypnotherapy

Other

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 outcomes

  1. Sedative effects of hypnotherapy and the drug "midazolam" indicated by anxiety scores and bispectral index (BIS) monitoring

    Time frame: during transesophageal echocardiography

Secondary outcomes

  1. measurement of alertness after sedation with continuous performance test (CPT)

    Time frame: the same time frame

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Hypnosis for Sedation in Transesophageal Echocardiography: Comparison With Midazolam

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 13, 2012
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.