Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Surgery With General Anesthesia |
Procedure: Automatic administration of propofol and opiates during routine clinical practice |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation |
- 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 ]
| Enrollment: | 180 |
| Study Start Date: | October 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients undergoing a 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. |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing a surgery with general anesthesia
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00764855 History of Changes |
| Other Study ID Numbers: | 2008/250 |
| Study First Received: | October 1, 2008 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Anesthetics Propofol Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Hypnotics and Sedatives |
ClinicalTrials.gov processed this record on May 19, 2013