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
  Purpose

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 Intervention Phase
Hypotension
Drug: pethidin hydrochlorid, midazolam
Drug: Propofol
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kantonsspital Münsterlingen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567657

Locations
Switzerland
Kantonsspital Münsterlingen
Münsterlingen, Kanton Thurgau, Switzerland, 8596
Sponsors and Collaborators
Kantonsspital Münsterlingen
Investigators
Study Director: Fritz Widmer, Dr. med. Departement of Cardiology, Kantonsspital Münsterlingen
  More Information

No publications provided

Responsible Party: Kantonsspital Münsterlingen
ClinicalTrials.gov Identifier: NCT01567657     History of Changes
Other Study ID Numbers: TEE 2012
Study First Received: January 4, 2012
Last Updated: January 25, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Münsterlingen:
Sedation in TEE
Blood pressure drop during TEE
Safety of sedation in TEE

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Propofol
Midazolam
Meperidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014