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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Surgery With General Anesthesia

Treatments

Procedure: Automatic administration of propofol and opiates during routine clinical practice

Study type

Observational

Funder types

Other

Identifiers

NCT00764855
2008/250

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

1
Description:
Patients undergoing a surgery with general anesthesia
Treatment:
Procedure: Automatic administration of propofol and opiates during routine clinical practice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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