Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567657
• Other study ID #: TEE 2012
• Status: Completed
• Phase: Phase 2
• First received: January 4, 2012
• Last updated: January 25, 2013
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Kantonsspital Münsterlingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Kanton Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Münsterlingen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a blood pressure drop of more than 30 mmHg and below 100 mmHg systolic		During examination (TEE), expected to be ca. 30 minutes	Yes
Secondary	Number of patients with adverse events		At time of transfer to the ward, expected to be after ca. 1 hour	No