Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
This study has been completed.
Information provided by (Responsible Party):
First received: January 4, 2012
Last updated: January 25, 2013
Last verified: January 2013
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).
Drug: pethidin hydrochlorid, midazolam
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
||Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
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.
- Pethidin hydrochlorid = Meperidine (USA)
- Midazolam = Dormicum
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.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- < 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01567657
|Münsterlingen, Kanton Thurgau, Switzerland, 8596 |
||Fritz Widmer, Dr. med.
||Departement of Cardiology, Kantonsspital Münsterlingen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2012
||January 25, 2013
Keywords provided by Kantonsspital Münsterlingen:
Sedation in TEE
Blood pressure drop during TEE
Safety of sedation in TEE
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 04, 2016
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents