Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
Information source: Kantonsspital Münsterlingen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypotension
Intervention: pethidin hydrochlorid, midazolam (Drug); Propofol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Kantonsspital Münsterlingen Official(s) and/or principal investigator(s): Fritz Widmer, Dr. med., Study Director, Affiliation: Departement of Cardiology, Kantonsspital Münsterlingen
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
Primary outcome: Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic
Secondary outcome: Number of patients with adverse events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kantonsspital Münsterlingen, Münsterlingen, Kanton Thurgau 8596, Switzerland
Additional Information
Starting date: January 2012
Last updated: January 25, 2013
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