AnesthesiaNCT02893904
EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol
A study testing EEG monitoring in people with Anesthesia, run by Hôpital Armand Trousseau at 1 site in France.
Trial summary
A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- EEG monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Dec 2006
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery
Who cannot join
- obesity (body mass index > percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.
A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.
The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.
Read the detailed description
Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.
Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.
At the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.
- Conditions
- Anesthesia
- Being tested
- EEG monitoring, Target Controlled Infusion
- Keywords
- Propofol, Sevoflurane, Bispectral Index, Children, Electroencephalographic signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG monitoringDevice
Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.
Target Controlled InfusionDevice
Also called TCI
Steady state effect site concentrations of remifentanil administrated to all patients.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | General anesthesia by TCI Propofol and Remifentanil guided by BIS EEG monitoring intervention Receives: Device: EEG monitoring; Device: Target Controlled Infusion |
| Sevoflurane | Experimental | General anesthesia by Sevoflurane and Remifentanil guided by BIS EEG monitoring intervention Receives: Device: EEG monitoring; Device: Target Controlled Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral profiles
For each patient, before surgery and according to the constraints of operating schedule, one or two 10 min steady state periods were performed at a fixed FeS randomized between 1, 2, 3, 4 and 5 % of Sevoflurane in the Sevoflurane group or at a fixed Ct P randomized between 2, 3, 4, 5 and 6 mcg/ml in the propofol group.
Measured: The average value of BIS is calculated on the last minute of each ten minutes steady state period .
Secondary outcomes (2)
Incidence of epileptiform EEG signs
Measured: Last minute of each ten minutes steady state period
Spectral analysis of EEG signal
Measured: Last minute of each ten minutes steady state period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2005
- Primary completionDec 2006
- Study completionDec 2006
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.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Armand Trousseau
- Sponsor type
- University, hospital or other
- Collaborators
- Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
- Responsible party
- Principal investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893904
- Sponsor's protocol ID
- BIS and EEG
- Status last verified
- Jul 2020
- First submitted
- 21 Jan 2016
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.
- ClinicalTrials.gov ID
- NCT02893904
- Acronym / sponsor ID
- BIS and EEG
- Conditions
- Anesthesia
- Keywords
- Propofol, Sevoflurane, Bispectral Index, Children, Electroencephalographic signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hôpital Armand TrousseauUniversity, hospital or other
- Collaborators
- Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
- Study start
- Jan 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Sep 2016 (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.
A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.
The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.
Detailed description
Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.
Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.
At the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Device: EEG monitoring, Device: Target Controlled InfusionGeneral anesthesia by TCI Propofol and Remifentanil guided by BIS EEG monitoring intervention |
| Sevoflurane | Experimental | Device: EEG monitoring, Device: Target Controlled InfusionGeneral anesthesia by Sevoflurane and Remifentanil guided by BIS EEG monitoring intervention |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery
Key exclusion criteria (1 listed)
- obesity (body mass index > percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system
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 |
|---|---|---|
| EEG monitoringSteady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients. | Device | Propofol, Sevoflurane |
| Target Controlled InfusionAlso: TCISteady state effect site concentrations of remifentanil administrated to all patients. | Device | Propofol, Sevoflurane |
Primary outcome
Bispectral profiles
Time frame: The average value of BIS is calculated on the last minute of each ten minutes steady state period .
For each patient, before surgery and according to the constraints of operating schedule, one or two 10 min steady state periods were performed at a fixed FeS randomized between 1, 2, 3, 4 and 5 % of Sevoflurane in the Sevoflurane group or at a fixed Ct P randomized between 2, 3, 4, 5 and 6 mcg/ml in the propofol group.
2 secondary outcomes
Incidence of epileptiform EEG signs
Time frame: Last minute of each ten minutes steady state period
Spectral analysis of EEG signal
Time frame: Last minute of each ten minutes steady state period
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 9 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG monitoring in people with Anesthesia, run by Hôpital Armand Trousseau at 1 site in France.
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 1 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 9 Jul 2020. 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 France. 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?
Bispectral profiles (time frame: The average value of BIS is calculated on the last minute of each ten minutes steady state period .). 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 9 Jul 2020; AzTrials last refreshed its copy on 30 Oct 2026.