Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

NCT ID: NCT01567657

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

pethidin hydrochlorid, midazolam

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

Other Intervention Names

Pethidin hydrochlorid = Meperidine (USA); Midazolam = Dormicum; Propofol = Propofolum = Diprivan = Disoprivan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Münsterlingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fritz Widmer, Dr. med.

Role: STUDY_DIRECTOR

Departement of Cardiology, Kantonsspital Münsterlingen

Locations

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, Switzerland

Countries

Switzerland

Other Identifiers

TEE 2012

Identifier Type: -

Identifier Source: org_study_id