Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

Phase 2

Completed

• Conditions: Hypotension
• Interventions: Drug: Propofol; Drug: pethidin hydrochlorid, midazolam

• Registration Number: NCT01567657
• Lead Sponsor: Kantonsspital Münsterlingen

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pethidin plus midazolam	Propofol	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.
Propofol	pethidin hydrochlorid, midazolam	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic	During examination (TEE), expected to be ca. 30 minutes

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events	At time of transfer to the ward, expected to be after ca. 1 hour

Trial Locations

Locations (1)

Kantonsspital Münsterlingen; 🇨🇭 Münsterlingen, Kanton Thurgau, Switzerland