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Completed

NCT Number: NCT01567657

Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

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).

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pethidin hydrochlorid, midazolam

Drug

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.

Other names: Pethidin hydrochlorid = Meperidine (USA), Midazolam = Dormicum

Propofol

Drug

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 names: Propofol = Propofolum = Diprivan = Disoprivan

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: At time of transfer to the ward, expected to be after ca. 1 hour

Sponsors and collaborators

Lead sponsor

Kantonsspital Münsterlingen

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 30, 2012
Registry last updated
Jan 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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