Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

• ClinicalTrials.gov Identifier: NCT01567657
• Recruitment Status: Completed
• First Posted: March 30, 2012
• Last Update Posted: January 28, 2013
• Sponsor: Kantonsspital Münsterlingen
• Information provided by (Responsible Party): Kantonsspital Münsterlingen

Tracking Information

• First Submitted Date: January 4, 2012
• First Posted Date: March 30, 2012
• Last Update Posted Date: January 28, 2013
• Study Start Date: January 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 29, 2012): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01567657 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: March 29, 2012): Number of patients with adverse events [ Time Frame: At time of transfer to the ward, expected to be after ca. 1 hour ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant)
• Condition: Hypotension

Intervention

• 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 Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 29, 2012): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01567657
• Other Study ID Numbers: TEE 2012
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kantonsspital Münsterlingen
• Study Sponsor: Kantonsspital Münsterlingen
• Collaborators: Not Provided

Investigators

• Study Director: Fritz Widmer, Dr. med.; Departement of Cardiology, Kantonsspital Münsterlingen

• PRS Account: Kantonsspital Münsterlingen
• Verification Date: January 2013