Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
|ClinicalTrials.gov Identifier: NCT01567657|
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : January 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypotension||Drug: pethidin hydrochlorid, midazolam Drug: Propofol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
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: 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.
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.
- 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 ]
- Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567657
|Münsterlingen, Kanton Thurgau, Switzerland, 8596|
|Study Director:||Fritz Widmer, Dr. med.||Departement of Cardiology, Kantonsspital Münsterlingen|