Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

Tracking Information
First Submitted Date ICMJE	January 4, 2012
First Posted Date ICMJE	March 30, 2012
Last Update Posted Date	January 28, 2013
Study Start Date ICMJE	January 2012
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 29, 2012)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01567657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 29, 2012)	Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Official Title ICMJE	Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort
Brief Summary	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).
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant)
Condition ICMJE	Hypotension
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 29, 2012)	200
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	January 2013
Actual Primary Completion Date	January 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 90 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Switzerland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01567657
Other Study ID Numbers ICMJE	TEE 2012
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Kantonsspital Münsterlingen
Study Sponsor ICMJE	Kantonsspital Münsterlingen
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Fritz Widmer, Dr. med. Departement of Cardiology, Kantonsspital Münsterlingen
PRS Account	Kantonsspital Münsterlingen
Verification Date	January 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP