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

NCT00764855 | Completed

• 1 other identifier: 2008/250
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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 "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.

Conditions

Surgery With General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

Patients undergoing a surgery with general anesthesia

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

Interventions

Automatic administration of propofol and opiates during routine clinical practice PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a surgery with general anesthesia

You may qualify if:

• Patients undergoing a surgery with general anesthesia
• Between 18 and 65 years of age
• Patient signed an informed consent

You may not qualify if:

• Patients that did not signed an informed consent

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• Neckebroek M, Boldingh JHL, De Smet T, Struys MMRF. Influence of Remifentanil on the Control Performance of the Bispectral Index Controlled Bayesian-Based Closed-Loop System for Propofol Administration. Anesth Analg. 2020 Jun;130(6):1661-1669. doi: 10.1213/ANE.0000000000004208.

  PMID: 31107260 DERIVED

Related Links

• Website of the University Hospital Ghent

Study Officials

• Michel Struys, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

BE (1)