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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00764855
Enrollment
180
Registered
2008-10-02
Start date
2008-10-31
Completion date
2011-08-31
Last updated
2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery With General Anesthesia

Brief summary

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.

Interventions

PROCEDUREAutomatic 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.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 practiceEnd of study

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026