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Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00764855
First received: October 1, 2008
Last updated: May 4, 2012
Last verified: May 2012

October 1, 2008
May 4, 2012
October 2008
August 2011   (final data collection date for primary outcome measure)
To analyse and to validate the "closed-loop system" of the optimal function of this system for automatic administration of propofol and opiates during routine clinical practice [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00764855 on ClinicalTrials.gov Archive Site
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Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation

Sleeping medication and analgesia are standard administered during anesthesia. Sleeping medication, Propofol (Diprivan, AstraZeneca), and analgesia, Remifentanil (GlaxoSmithKline), are most frequently used In the University Hospital Ghent.

The clinical effect of administration of pharmaca can be measured in the changes of heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG. These measurements are performed standard, to secure the safety of the patient.

The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of the patient.

The blood pressure will be measured by non invasive blood pressure cuff around the arm and the respiration parameters will be measured by non invasive spirometry, which are all standard available on a anesthesia device.

Most of the pharmaca are administered by a fixed dosage schedule based on the patient's weight.

A more individualized administration of this pharmaca could lead to a better anesthesia quality.

Since considerable time, we know that a computer-controlled administration of these products by automatic coupling between the measured effects and the "spuit"pump to administer the product, could lead to a better administration, optimalisation of the administered dose, because the patients individual effect of the administration can be taken in consideration. This device is called the "closed-loop system". The department of Anesthesia has already proofed the utility of the device for automatic administration of Propofol and opiates in small specific patient groups.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients undergoing a surgery with general anesthesia

Surgery With General Anesthesia
Procedure: Automatic administration of propofol and opiates during routine clinical practice

The clinical effect of administration of pharmaca can be measured in the changes of heartbeat, blood pressure, respiration and the changes of brain activity by registering EEG. These measurements are performed standard, to secure the safety of the patient.

The heartbeat and the EEG will be measured by non invasive adhesive electrodes on the skin of the patient.

The blood pressure will be measured by non invasive blood pressure cuff around the arm and the respiration parameters will be measured by non invasive spirometry, which are all standard available on a anesthesia device.

1
Patients undergoing a surgery with general anesthesia
Intervention: Procedure: Automatic administration of propofol and opiates during routine clinical practice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing a surgery with general anesthesia
  • Between 18 and 65 years of age
  • Patient signed an informed consent

Exclusion Criteria:

  • Patients that did not signed an informed consent
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00764855
2008/250
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent
University Hospital, Ghent
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP