Surgery With General Anesthesia Clinical Trial
Official title:
Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
| Verified date | May 2012 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | August 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |