General AnesthesiaSIZENCT00775879
Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
A study testing Induction with Sevoflurane in people with General Anesthesia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Induction with Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2006to Jul 2008
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- programmed gynecological surgery
- ASA 1 or 2
Who cannot join
- arterial hypertension
- gastro-oesophageal reflux
- pregnancy
- diabetes
- obesity
- asthma
- tobacco
Trial locations and contacts
1 site in 1 country.
About this study
Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence.
- Conditions
- General Anesthesia
- Being tested
- Induction with Sevoflurane
- Keywords
- Général anesthesia, Gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction with SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 2.5% target concentration Receives: Drug: Induction with Sevoflurane |
| B | Active comparator | 2.5% manually selected Receives: Drug: Induction with Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spike wave
Measured: during anaesthesia induction with sevoflurane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionJul 2008
- Study completionJul 2008
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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin JULLIAC, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775879
- Sponsor's protocol ID
- CHUBX 2004/01
- Acronym
- SIZE
- Status last verified
- May 2013
- First submitted
- 17 Oct 2008
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Nouette-Gaulain K, Lemoine P, Cros AM, Sztark F. [Induction of anaesthesia with target-controlled inhalation of sevoflurane in adults with the ZEUS anaesthesia machine]. Ann Fr Anesth Reanim. 2005 Jul;24(7):802-6. doi: 10.1016/j.annfar.2005.04.029. French.
PubMed 15949912
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Induction With Target-controlled Inhalation of Sevoflurane on Spikes Wave Occurrence
- ClinicalTrials.gov ID
- NCT00775879
- Acronym / sponsor ID
- SIZE / CHUBX 2004/01
- Conditions
- General Anesthesia
- Keywords
- Général anesthesia, Gynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 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.
Sevoflurane is widely used for induction of anaesthesia. Several studies showed EEG abnormalities during mask induction with sevoflurane. The aim of our study was to test the induction target concentration of sevoflurane on the spikes wave occurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Induction with Sevoflurane2.5% target concentration |
| B | Active comparator | Drug: Induction with Sevoflurane2.5% manually selected |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- programmed gynecological surgery
- ASA 1 or 2
Key exclusion criteria (7 listed)
- arterial hypertension
- gastro-oesophageal reflux
- pregnancy
- diabetes
- obesity
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 |
|---|---|---|
| Induction with Sevoflurane | Drug | A, B |
Primary outcome
Incidence of spike wave
Time frame: during anaesthesia induction with sevoflurane
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 18 Jun 2026.
- Results publication: PubMed 15949912Nouette-Gaulain K, Lemoine P, Cros AM, Sztark F. [Induction of anaesthesia with target-controlled inhalation of sevoflurane in adults with the ZEUS anaesthesia machine]. Ann Fr Anesth Reanim. 2005 Jul;24(7):802-6. doi: 10.1016/j.annfar.2005.04.029. French.
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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.
Benjamin JULLIAC, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induction with Sevoflurane in people with General Anesthesia, run by University Hospital, Bordeaux 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 2 inclusion and 7 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 18 Jun 2026. 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?
Incidence of spike wave (time frame: during anaesthesia induction with sevoflurane). 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 NCT00775879, 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 18 Jun 2026.