Safety Study of Two Regimen for Sedation for Transesophageal Echocardiography

NCT01567657 | Completed Phase 2

• 1 other identifier: TEE 2012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypotension

Keywords

Sedation in TEE; Blood pressure drop during TEE; Safety of sedation in TEE

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of patients with adverse events

  At time of transfer to the ward, expected to be after ca. 1 hour

Study Arms (2)

Pethidin plus midazolam

ACTIVE COMPARATOR

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

Propofol

ACTIVE COMPARATOR

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

Interventions

pethidin hydrochlorid, midazolam DRUG

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.

Also known as: Pethidin hydrochlorid = Meperidine (USA), Midazolam = Dormicum

Propofol

Propofol DRUG

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.

Also known as: Propofol = Propofolum = Diprivan = Disoprivan

Pethidin plus midazolam

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Kantonsspital Münsterlingen: lead

Study Sites (1)

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

Location

MeSH Terms

Conditions

Hypotension

Interventions

Midazolam; Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Fritz Widmer, Dr. med.

  Departement of Cardiology, Kantonsspital Münsterlingen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: March 30, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

CH (1)