AnesthesiaPhase 2NCT00522587

Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance

A Phase 2 study testing Fixed sevoflurane dose 1, Fixed sevoflurane dose 2 and Fixed sevoflurane dose 3 in people with Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Anesthesia
What is being tested?: Fixed sevoflurane dose 1, Fixed sevoflurane dose 2 and Fixed sevoflurane dose 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBelgium
Study dates: Apr 2008to Dec 2011
Phase: Phase 2
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

American Society of Anesthesia class I and II patients
Aged 18-60 years
Scheduled for surgery under general anesthesia

Who cannot join

Weight less than 70% or more than 130% of ideal body weight
Neurological disorder
Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator [AICD])
Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
Gastric diseases including reflux, endocrinological diseases
Recent use of psycho-active medication, including alcohol.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Ghent
Ghent, 9000

Other trials in Belgium

About this study

During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Conditions: Anesthesia
Being tested: Fixed sevoflurane dose 1, Fixed sevoflurane dose 2, Fixed sevoflurane dose 3, Fixed sevoflurane dose 4, Fixed sevoflurane dose 5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed sevoflurane dose 1Drug
Dose 1 of sevoflurane
Fixed sevoflurane dose 2Drug
Dose 2 of sevoflurane
Fixed sevoflurane dose 3Drug
Dose 3 of sevoflurane
Fixed sevoflurane dose 4Drug
Dose 4 of sevoflurane
Fixed sevoflurane dose 5Drug
Dose 5 of sevoflurane
Fixed sevoflurane dose 6Drug
Dose 6 of sevoflurane
Fixed remifentanil dose 1Drug
Dose 1 of remifentanil
Fixed remifentanil dose 2Drug
Dose 2 of remifentanil
Fixed remifentanil dose 3Drug
Dose 3 of remifentanil
Fixed remifentanil dose 4Drug
Dose 4 of remifentanil
Fixed remifentanil dose 5Drug
Dose 5 of remifentanil
Fixed remifentanil dose 6Drug
Dose 6 of remifentanil

Study groups in NCT00522587
Study group	Role	What they receive
1	Experimental	Fixed sevoflurane dose 1 Receives: Drug: Fixed sevoflurane dose 1
2	Experimental	Fixed sevoflurane dose 2 Receives: Drug: Fixed sevoflurane dose 2
3	Experimental	Fixed sevoflurane dose 3 Receives: Drug: Fixed sevoflurane dose 3
4	Experimental	Fixed sevoflurane dose 4 Receives: Drug: Fixed sevoflurane dose 4
5	Experimental	Fixed sevoflurane dose 5 Receives: Drug: Fixed sevoflurane dose 5
6	Experimental	Fixed sevoflurane dose 6 Receives: Drug: Fixed sevoflurane dose 6
7	Experimental	Fixed remifentanil dose 1 Receives: Drug: Fixed remifentanil dose 1
8	Experimental	Fixed remifentanil dose 2 Receives: Drug: Fixed remifentanil dose 2
9	Experimental	Fixed remifentanil dose 3 Receives: Drug: Fixed remifentanil dose 3
10	Experimental	Fixed remifentanil dose 4 Receives: Drug: Fixed remifentanil dose 4
11	Experimental	Fixed remifentanil dose 5 Receives: Drug: Fixed remifentanil dose 5
12	Experimental	Fixed remifentanil dose 6 Receives: Drug: Fixed remifentanil dose 6

What is being measured

The primary outcome is the main question the study is designed to answer.

EEG depression and arousal reactions in response to different clinically relevant stimuli
Measured: 60 to 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Dec 2011

First posted29 Aug 2007 (estimated)
Study startApr 2008
Primary completionJul 2009
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00522587
Sponsor's protocol ID: 2007/242
Status last verified: Jan 2013
First submitted: 27 Aug 2007
Last updated: 30 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
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Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
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Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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All Anesthesia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance
ClinicalTrials.gov ID: NCT00522587
Acronym / sponsor ID: 2007/242
Conditions: Anesthesia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University Hospital, GhentUniversity, hospital or other
Study start: Apr 2008
Primary completion: Jul 2009 (actual)
Study completion: Dec 2011 (actual)
First posted: 29 Aug 2007 (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.

During this study, the pharmacodynamic interactions between sevoflurane and remifentanil will be studied.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 12

Arm	Type	Receives
1	Experimental	Drug: Fixed sevoflurane dose 1Fixed sevoflurane dose 1
2	Experimental	Drug: Fixed sevoflurane dose 2Fixed sevoflurane dose 2
3	Experimental	Drug: Fixed sevoflurane dose 3Fixed sevoflurane dose 3
4	Experimental	Drug: Fixed sevoflurane dose 4Fixed sevoflurane dose 4
5	Experimental	Drug: Fixed sevoflurane dose 5Fixed sevoflurane dose 5
6	Experimental	Drug: Fixed sevoflurane dose 6Fixed sevoflurane dose 6
7	Experimental	Drug: Fixed remifentanil dose 1Fixed remifentanil dose 1
8	Experimental	Drug: Fixed remifentanil dose 2Fixed remifentanil dose 2
9	Experimental	Drug: Fixed remifentanil dose 3Fixed remifentanil dose 3
10	Experimental	Drug: Fixed remifentanil dose 4Fixed remifentanil dose 4
11	Experimental	Drug: Fixed remifentanil dose 5Fixed remifentanil dose 5
12	Experimental	Drug: Fixed remifentanil dose 6Fixed remifentanil dose 6

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

American Society of Anesthesia class I and II patients
Aged 18-60 years
Scheduled for surgery under general anesthesia

Key exclusion criteria (6 listed)

Weight less than 70% or more than 130% of ideal body weight
Neurological disorder
Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction (AMI), any valvular and/or muscular disease involving decrease of the ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic implantable cardioverter defibrillator [AICD])
Pulmonary disease including asthma, severe chronic obstructive pulmonary disease (COPD), etc.
Gastric diseases including reflux, endocrinological diseases

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
Fixed sevoflurane dose 1Dose 1 of sevoflurane	Drug	1
Fixed sevoflurane dose 2Dose 2 of sevoflurane	Drug	2
Fixed sevoflurane dose 3Dose 3 of sevoflurane	Drug	3
Fixed sevoflurane dose 4Dose 4 of sevoflurane	Drug	4
Fixed sevoflurane dose 5Dose 5 of sevoflurane	Drug	5
Fixed sevoflurane dose 6Dose 6 of sevoflurane	Drug	6
Fixed remifentanil dose 1Dose 1 of remifentanil	Drug	7
Fixed remifentanil dose 2Dose 2 of remifentanil	Drug	8
Fixed remifentanil dose 3Dose 3 of remifentanil	Drug	9
Fixed remifentanil dose 4Dose 4 of remifentanil	Drug	10
Fixed remifentanil dose 5Dose 5 of remifentanil	Drug	11
Fixed remifentanil dose 6Dose 6 of remifentanil	Drug	12

Primary outcome

EEG depression and arousal reactions in response to different clinically relevant stimuli
Time frame: 60 to 90 minutes

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 30 Jan 2013.
Website of the University Hospital GhentLink provided by the sponsor.

Related trials for Anesthesia

Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia

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?

A Phase 2 study testing Fixed sevoflurane dose 1, Fixed sevoflurane dose 2 and Fixed sevoflurane dose 3 in people with 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 6 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 30 Jan 2013. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

EEG depression and arousal reactions in response to different clinically relevant stimuli (time frame: 60 to 90 minutes). 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 NCT00522587.

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 30 Jan 2013.