Working… Menu

Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567657
Recruitment Status : Completed
First Posted : March 30, 2012
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Hypotension Drug: pethidin hydrochlorid, midazolam Drug: Propofol Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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 Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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.
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

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.
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

Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01567657

Layout table for location information
Kantonsspital Münsterlingen
Münsterlingen, Kanton Thurgau, Switzerland, 8596
Sponsors and Collaborators
Kantonsspital Münsterlingen
Layout table for investigator information
Study Director: Fritz Widmer, Dr. med. Departement of Cardiology, Kantonsspital Münsterlingen

Layout table for additonal information
Responsible Party: Kantonsspital Münsterlingen Identifier: NCT01567657     History of Changes
Other Study ID Numbers: TEE 2012
First Posted: March 30, 2012    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Keywords provided by Kantonsspital Münsterlingen:
Sedation in TEE
Blood pressure drop during TEE
Safety of sedation in TEE
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents