Surgery With General AnesthesiaNCT00764855
Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
An observational study of Surgery With General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Surgery With General Anesthesia
- What is being tested?
- Automatic administration of propofol and opiates during routine clinical practice
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing a surgery with general anesthesia
Who may be able to join
- Patients undergoing a surgery with general anesthesia
- Between 18 and 65 years of age
- Patient signed an informed consent
Who cannot join
- Patients that did not signed an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Automatic administration of propofol and opiates during routine clinical practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic administration of propofol and opiates during routine clinical practiceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing a surgery with general anesthesia Receives: Procedure: Automatic administration of propofol and opiates during routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery With General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Struys, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764855
- Sponsor's protocol ID
- 2008/250
- Status last verified
- May 2012
- First submitted
- 1 Oct 2008
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31107260
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Effect of Propofol and Opiates Closed-loop Administration Device During Anesthesia and Sedation
- ClinicalTrials.gov ID
- NCT00764855
- Acronym / sponsor ID
- 2008/250
- Conditions
- Surgery With General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Automatic administration of propofol and opiates during routine clinical practicePatients undergoing a surgery with general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a surgery with general anesthesia
Key inclusion criteria (3 listed)
- Patients undergoing a surgery with general anesthesia
- Between 18 and 65 years of age
- Patient signed an informed consent
Key exclusion criteria (1 listed)
- Patients that did not signed an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic administration of propofol and opiates during routine clinical practiceThe 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. | Procedure or surgery | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
- Derived from this study: PubMed 31107260Neckebroek 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.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Struys, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery With General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.