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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00764855
First received: October 1, 2008
Last updated: May 4, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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
Study Population

Patients undergoing a surgery with general anesthesia

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764855

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent
  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
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014