Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kantonsspital Münsterlingen

ClinicalTrials.gov Identifier:

NCT01567657

First received: January 4, 2012

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 4, 2012

Last Updated Date

January 25, 2013

Start Date ^ICMJE

January 2012

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01567657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

Official Title ^ICMJE

Phase II Study of Comparison of Two Sedation Regimen for Transesophageal Echocardiography in Point of View of Blood Pressure Response, Safety and Patient Comfort

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Hypotension

Intervention ^ICMJE

Drug: 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.
Other Names:
- Pethidin hydrochlorid = Meperidine (USA)
- Midazolam = Dormicum
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.

Other Name: Propofol = Propofolum = Diprivan = Disoprivan

Study Arm (s)

Active Comparator: 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.

Intervention: Drug: Propofol
Active Comparator: 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.

Intervention: Drug: pethidin hydrochlorid, midazolam

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01567657

Other Study ID Numbers ^ICMJE

TEE 2012

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Kantonsspital Münsterlingen

Study Sponsor ^ICMJE

Kantonsspital Münsterlingen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Fritz Widmer, Dr. med.

Departement of Cardiology, Kantonsspital Münsterlingen

Information Provided By

Kantonsspital Münsterlingen

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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