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

Study Overview
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Brief Summary
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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 spuitpump 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.

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

Conditions
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Surgery With General Anesthesia

Intervention / Treatment
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* Procedure: Automatic administration of propofol and opiates during routine clinical practice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients undergoing a surgery with general anesthesia | Procedure: Automatic administration of propofol and opiates during routine clinical practice<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | End of study |