Middle Aged PatientsPhase 4NCT01662622
Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
A Phase 4 study testing Sevoflurane in people with Middle Aged Patients and Sevoflurane, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Middle Aged Patients, Sevoflurane, General Anesthesia
- What is being tested?
- Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jul 2012
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-65yr
- upper abdominal surgery in general anaesthesia
- ASA physical status classification of I or II
Who cannot join
- neurological disease
- received central nervous system-active drugs
- cardiac ejection fraction less than 40%
- history of difficult intubation or anticipated difficult intubation
- daily alcohol consumption
- obesity, defined as a body-mass index of more than 30
- without informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.
Read the detailed description
Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize. General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium. After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.
- Conditions
- Middle Aged Patients, Sevoflurane, General Anesthesia
- Being tested
- Sevoflurane
- Keywords
- anaesthesia, middle aged, minimal alveolar concentration, sevoflurane, isoelectric EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
The design of experiment is referred to the "Dixon up-and-down" method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Anaesthesia was induced by 8% sevoflurane. Cisatracurium 0.15mg kg-1 was administered after loss of the lash reflex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1. Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°). The surgical incision was performed at least 30min after tracheal intubation. When arterial blood pressure (MAP) decrease exceeding 20% of baseline values. Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACie
Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
Measured: 30min
Secondary outcomes (1)
MACbs
Minimal Alveolar Concentration of sevoflurane inducing inducing burst suppression EEG (MACbs) in middle aged adults.
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle Aged PatientsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China, National Natural Science Foundation of China
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, MD., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662622
- Sponsor's protocol ID
- TJMZK20120301
- Status last verified
- Aug 2012
- First submitted
- 8 Aug 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
- ClinicalTrials.gov ID
- NCT01662622
- Acronym / sponsor ID
- TJMZK20120301
- Conditions
- Middle Aged Patients, Sevoflurane, General Anesthesia
- Keywords
- anaesthesia, middle aged, minimal alveolar concentration, sevoflurane, isoelectric EEG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Ministry of Health, China, National Natural Science Foundation of China
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Aug 2012 (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 can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.
Detailed description
Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize. General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium. After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneAnaesthesia was induced by 8% sevoflurane. Cisatracurium 0.15mg kg-1 was administered after loss of the lash reflex, then ventilated manually until the amplitude of T1 decreased to 0. Intubation was performed and switched to mechanical ventilation with a fresh gas flow 2L min-1. Gas concentrations were analysed using a gas analyser.The end-tidal concentration of carbon dioxide was maintained at 4.7kPa; an esophageal temperature probe was inserted and a warming unit was used if necessary to maintain normothermia (35.5°-38.5°). The surgical incision was performed at least 30min after tracheal intubation. When arterial blood pressure (MAP) decrease exceeding 20% of baseline values. Phenylephrine 0.1mg was administered intravenously if necessary to maintained MAP and recorded. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45-65yr
- upper abdominal surgery in general anaesthesia
- ASA physical status classification of I or II
Key exclusion criteria (7 listed)
- neurological disease
- received central nervous system-active drugs
- cardiac ejection fraction less than 40%
- history of difficult intubation or anticipated difficult intubation
- daily alcohol consumption
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 |
|---|---|---|
| SevofluraneThe design of experiment is referred to the "Dixon up-and-down" method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted. | Drug | Sevoflurane |
Primary outcome
MACie
Time frame: 30min
Minimal Alveolar Concentration of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie)
1 secondary outcome
MACbs
Time frame: 30 min
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 14 Aug 2012.
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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.
Yuke Tian, MD. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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 Sevoflurane in people with Middle Aged Patients and Sevoflurane, run by Huazhong University of Science and Technology at 1 site in China.
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 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 14 Aug 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 China. 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 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?
MACie (time frame: 30min). 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 14 Aug 2012.