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Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier:
NCT01567657
First received: January 4, 2012
Last updated: January 25, 2013
Last verified: January 2013

January 4, 2012
January 25, 2013
January 2012
January 2013   (final data collection date for primary outcome measure)
Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic [ Time Frame: During examination (TEE), expected to be ca. 30 minutes ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01567657 on ClinicalTrials.gov Archive Site
Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort

The purpose of this study is to determine whether sedation with a combination of pethidin hydrochlorid plus midazolam intravenously (i.v.) is superior to propofol i.v. alone in relation to blood pressure drops during an transesophageal echocardiographic examination (TEE).

Randomisation is done immediately after information of the patient and obtaining of the informed consent. The average time for a TEE study is about 30 minutes. Data collection occurs during this time frame. ECG monitoring and data collection (blood pressure, heart rate, SO2) for the study protocol starts 6 minutes before the application of the sedation. At -6, -4, -2 minutes before the application of the sedation, baseline data are collected. The average systolic blood pressure of these three measures is taken as the reference blood pressure. This is the reference value to calculate the blood pressure drop during the examination. Blood pressure, pulse oxymetry, heart rate are taken every 2 minutes until the examination (TEE) is finished. The questionnaire (for second end points) is filled out by the patient within two hours after the examination. The patient will be followed for the duration of about one hour after the examination, if he is from the outpatient clinic. Patients from the hospital (inpatients) will be followed routinely in the clinic.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Hypotension
  • Drug: pethidin hydrochlorid, midazolam
    Pethidin hydrochlorid: 25 mg iv. at the beginning of the examination Midazolam: 1-2 mg iv. at the beginning of the examination. Repetitive given in a dosis of 1 mg iv. until a total amount of 7 mg iv.
    Other Names:
    • Pethidin hydrochlorid = Meperidine (USA)
    • Midazolam = Dormicum
  • Drug: Propofol

    50 years and over: initial dose of 50-60 mg Propofol iv. Followed by bolus of 20-30 mg iv. until sedation is achieved.

    < 50 years: initial dose 30-40 mg Propofol iv. Followed by bolus of 10-20 mg until sedation is achieved.

    Other Name: Propofol = Propofolum = Diprivan = Disoprivan
  • Active Comparator: Pethidin plus midazolam
    Initial dose of 25 mg Pethidin iv. plus 1-2 mg Midazolam iv. Additional Bolus of Midazolam (1 mg wise iv.) if needed, until a maximal dose of 7 mg Midazolam iv.
    Intervention: Drug: Propofol
  • Active Comparator: Propofol
    Initial dose of Propofol of 50-60 mg iv. for patients 50 years or younger. Initial dose of Propofol of 30-40 mg iv. for patients over 50 years. If needed additional Bolus of 20-30 mg Propofol iv. as usual until sedation is achieved.
    Intervention: Drug: pethidin hydrochlorid, midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients scheduled for TEE in our department who have signed the informed consent except those younger than 18 years and patients with a second or third etc. TEE

Exclusion Criteria:

  • < 18 years
  • intensive care patients
  • emergency department patients
  • breast feeding women
  • pregnant women
  • patients with an allergy to Propofol or its ingredient soy oil, Pethidin or Midazolam
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01567657
TEE 2012
No
Kantonsspital Münsterlingen
Kantonsspital Münsterlingen
Not Provided
Study Director: Fritz Widmer, Dr. med. Departement of Cardiology, Kantonsspital Münsterlingen
Kantonsspital Münsterlingen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP