DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017