ASA Class I/II Patients Scheduled for Surgery Under General AnesthesiaPhase 4NCT01103193
Nitrous Oxide - Sevoflurane-Remifentanil Interaction
A Phase 4 study testing remifentanil injected and sevoflurane in step up concentration in people with ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
patients are allocated to one of the two study groups. In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ASA Class I/II Patients Scheduled for Surgery Under General Anesthesia
- What is being tested?
- remifentanil injected and sevoflurane in step up concentration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2010to May 2010
- Phase
- Phase 4
- 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, pulmonary disease, gastric diseases, endocrinological diseases
- recent use of psycho-active medication, including alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrous Oxide - Sevoflurane-Remifentanil Interaction: Multiple Response Surfaces, Validation of Calibration Stimuli, Validation of the Intraoperative Isobole Concept and Investigating Remifentanil Induced Opioid Tolerance.
patients are allocated to one of the two study groups.
In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
Read more
During the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.
The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.
- Being tested
- remifentanil injected, sevoflurane in step up concentration
- Keywords
- ASA class I/II patients, with surgery under general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanil injectedDrug
mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.
sevoflurane in step up concentrationDrug
of 60% nitrous oxide and 40% oxygen is administered through a face mask.remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
| Study group | Role | What they receive |
|---|---|---|
| remifentanil injected | Active comparator | a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. Receives: Drug: remifentanil injected |
| sevoflurane in step up concentration | Active comparator | a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration. Receives: Drug: sevoflurane in step up concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil
The interaction is studied on response surfaces including several clinical endpoints: the observer assessment of alertness and sedation scale, the heart rate, pulse oximetry, blood pressure, EEG and the derived parameters from it: spectral entropy and BIS
Measured: Every 12 minutes during induction and maintenance of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA Class I/II Patients Scheduled for Surgery Under General AnesthesiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo Vereecke, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103193
- Sponsor's protocol ID
- 2009/493
- Status last verified
- May 2012
- First submitted
- 19 Mar 2010
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide - 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
- NCT01103193
- Acronym / sponsor ID
- 2009/493
- Keywords
- ASA class I/II patients, with surgery under general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Apr 2010 (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.
patients are allocated to one of the two study groups.
In both groups a mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. In the second group remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
During the study, at predefined times, we will assess different levels of sedation (OAA/S score) and the reaction on tetanic stimulation of the ulnar nerve, insertion of a laryngeal mask airway and laryngoscopy. In addition heart rate, SpO2 and capnography will be recorded continuously and non invasive bloodpressure will be recorded using a 1 minute interval time. Spectral entropy and BIS derived from the frontal EEG will be used to monitor clinical cerebral drug effect.
The null hypothesis is that remifentanil lowers the concentration of sevoflurane dissolved in a mixture of 60% nitrous oxide and 40% oxygen to (1) tolerate a specific stimulation and to (2) obtain a certain electroencephalographic parameter value and vice versa. Additionally the results of this study will be compared with a former interaction study of the same study group that did not involve nitrous oxide, in order to depict the shift in the response surface evoked by nitrous oxide.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| remifentanil injected | Active comparator | Drug: remifentanil injecteda mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. |
| sevoflurane in step up concentration | Active comparator | Drug: sevoflurane in step up concentrationa mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration. |
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 (4 listed)
- Weight less than 70% or more than 130% of ideal body weight
- neurological disorder
- diseases involving the cardiovascular system, pulmonary disease, gastric diseases, endocrinological diseases
- recent use of psycho-active medication, including alcohol
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 |
|---|---|---|
| remifentanil injectedmixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol. | Drug | remifentanil injected |
| sevoflurane in step up concentrationof 60% nitrous oxide and 40% oxygen is administered through a face mask.remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration. | Drug | sevoflurane in step up concentration |
Primary outcome
To investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil
Time frame: Every 12 minutes during induction and maintenance of anesthesia
The interaction is studied on response surfaces including several clinical endpoints: the observer assessment of alertness and sedation scale, the heart rate, pulse oximetry, blood pressure, EEG and the derived parameters from it: spectral entropy and BIS
Results and safety
The study was stopped early (reason given: Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- website University Hospital GhentLink provided by the sponsor.
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.
Hugo Vereecke, 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 4 study testing remifentanil injected and sevoflurane in step up concentration in people with ASA Class I/II Patients Scheduled for Surgery Under 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 4 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: stopped early, as of the sponsor's last update on 8 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Need of change to the protocol. As the Principal Investigator has left the University Hospital Ghent end 2010, the change of protocol was never submitted.). Results are not available in the source record.
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 investigate the pharmacodynamic interaction between nitrous oxide, sevoflurane and remifentanil (time frame: Every 12 minutes during induction and maintenance of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2012.