AnesthesiaNCT03559504
Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane
An observational study of Anesthesia, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This study is being conducted to evaluate and assess the electroencephalography wave patterns in different age patients undergoing surgery under general anesthesia. The aim of our study is to compare the raw EEG waves in different age patients and analyze any changes in these patterns among various age groups and… Read more about this study
- Who is it for?
- Ages 1 month to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Sevoflurane Inhal Soln
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 5 Sep 2018
- Phase
- Observational
- 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 1 month to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 120 patients undergoing minor elective surgeries will be allocated in 6 age groups: 0-1 year old (infant period), 1-3 years old (toddler period), 3-6 years old (preschool age period), 7-18 years old (school age period), 18-65 years old (adults) and 65-80 years old (elderly).
Who may be able to join
- Patients age between 0 to 80 years old
- American Society of Anesthesiologists (ASA) I or II scheduled for minor surgeries under general anesthesia lasting less than 2 hours each.
Who cannot join
- Potential subjects with any neurological or psychiatric disease
- Relative or absolute contraindication to sevoflurane including pregnancy by patient self-report
- Any recent prescription or illicit medication use will be excluded
- Patients with a history of any disabling central nervous or cerebrovascular disease
- Patients who had received central nervous system-active drugs
- Patients with poor quality data, most likely because of poor electrode contact.
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University and Yuying Children's Hospital of Wenzhou Medical University
Zhejiang, Zhejiang, 325027
About this study
This study is being conducted to evaluate and assess the electroencephalography wave patterns in different age patients undergoing surgery under general anesthesia. The aim of our study is to compare the raw EEG waves in different age patients and analyze any changes in these patterns among various age groups and which of these groups will have the EEG signal of high-frequency waves or low frequency waves. Previous studies have shown that light sedation is often accompanied by decreasing posterior alpha waves and increasing the intensity of frontal/central beta waves. It is therefore of neuroscientific interest to assess whether the electroencephalographic correlates of sevoflurane-induced unconsciousness have different or similar frequency range among the age groups.
Read the detailed description
EEG is a powerful tool that refers to the recording of the brain's spontaneous electrical activity along the scalp and it can be used to measure voltage fluctuations which result from ionic current flows within neurons found in the brain.The electroencephalogram is increasingly used to measure anesthetic drug effect on the central nervous system.The use of electroencephalographic monitors has been proven to decrease drug consumption during anesthesia and to lead to a faster recovery from anesthesia. Recently, the use of the Bispectral Index® (BIS®) monitor (Aspect Medical Systems, Newton, MA) has been shown to decrease the incidence of intraoperative awareness. Depth of anesthesia is frequently assessed using electroencephalogram processing systems, such as BIS and M-Entropy® (Datex-Ohmeda, Helsinki, Finland). The use of these monitors has been claimed to allow more accurate drug administration which has the theoretical benefit of avoiding phases of too light or too profound anesthesia and the associated risks of hemodynamic instability. Inadequate general anesthesia caused by under dosage causes intraoperative awareness whereas prolonged anesthesia increases the risk of postoperative complications because of over dosage. The most important factor that contributes to the inadequate general anesthesia is the current limited ability to determine the level of awareness. In this study, the investigators want to analyze the raw EEG waves under general anesthesia using sevoflurane of MAC 1.0 for different age groups from 0 to 80 years old. The relation between concentration of 1.0 MAC sevoflurane and raw EEG states in different age groups is relatively unstudied. In this prospective randomized study the investigators want to know if there is any correlation of brain waves under general anesthesia in different age groups. Given that the brain rapidly develops and undergoes significant changes from childbirth into adulthood, anesthesia induced EEG oscillations in children might differ from those of adults, and could vary significantly with age. Characterizing the structure of the EEG in relation to age would help establish the foundations for age-appropriate monitoring of brain states during general anesthesia and sedation in children. The investigators aimed to examine the effects of age on the EEG during general anesthesia, with sevoflurane as the sole hypnotic agent.
After arrival in the operating room, an intravenous line will be inserted into a large forearm vein, and standard monitors will be applied. Each patient will be continuously monitored by a 3-lead electrocardiogram, noninvasive arterial pressure, pulse oximetry, and end-tidal carbon dioxide concentration.
The induction of anesthesia will be the same in all age groups and will consist of sufentanil 0.2-0.3mcg/kg or fentanyl 1-2 mcg/kg before intubation and 0.2 mg/kg cisatracurium to facilitate intubation. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration. After tracheal intubation, patients will be ventilated with a tidal volume of 6-8 ml/kg and the respiratory rate will be adapted to obtain an end-tidal carbon dioxide concentration of 30-35 mmHg.
- Conditions
- Anesthesia
- Being tested
- Sevoflurane Inhal Soln
- Keywords
- electroencephalography, general anesthesia, sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane Inhal SolnDrug
Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Infant period: 1 month-1 year old Receives: Drug: Sevoflurane Inhal Soln | |
| Group 2 | Toddler period:1-3 years old Receives: Drug: Sevoflurane Inhal Soln | |
| Group 3 | Preschool age period:3-6 years old Receives: Drug: Sevoflurane Inhal Soln | |
| Group 4 | School age period:7-18 years old Receives: Drug: Sevoflurane Inhal Soln | |
| Group 5 | Adults:18-65 years old Receives: Drug: Sevoflurane Inhal Soln | |
| Group 6 | Elderly:65-80 years old Receives: Drug: Sevoflurane Inhal Soln |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography among various ages.
Monitoring the raw EEG changes among various ages. The raw EEG waves of each patient will be analyzed and the results will be compared among the groups. The investigators want to see if there is any difference of the EEG wave among the 6 groups under 1.0 MAC sevoflurane.
Measured: The experiment will be carried out for 10 mins after induction of anesthesia and before beginning of the surgery.
Secondary outcomes (1)
Morphology of electroencephalogram during 1.0 (MAC) Minimum Alveolar Concentration sevoflurane
The investigators will analyze raw EEG waves from 0 year old to 80 years old. The subjects will be divided into 6 groups according to their respective age. Sevoflurane will be maintained at 1.0 MAC for each age groups.
Measured: While the raw EEG wave is being recorded for a period of 10 mins, the investigators will adjust the concentration of sevoflurane bringing it to 1.0 MAC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 Feb 2018
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559504
- Sponsor's protocol ID
- SAHoWMU-CR2017-03-216
- Status last verified
- Sep 2018
- First submitted
- 3 Apr 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane
- ClinicalTrials.gov ID
- NCT03559504
- Acronym / sponsor ID
- SAHoWMU-CR2017-03-216
- Conditions
- Anesthesia
- Keywords
- electroencephalography, general anesthesia, sevoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
This study is being conducted to evaluate and assess the electroencephalography wave patterns in different age patients undergoing surgery under general anesthesia. The aim of our study is to compare the raw EEG waves in different age patients and analyze any changes in these patterns among various age groups and which of these groups will have the EEG signal of high-frequency waves or low frequency waves. Previous studies have shown that light sedation is often accompanied by decreasing posterior alpha waves and increasing the intensity of frontal/central beta waves. It is therefore of neuroscientific interest to assess whether the electroencephalographic correlates of sevoflurane-induced unconsciousness have different or similar frequency range among the age groups.
Detailed description
EEG is a powerful tool that refers to the recording of the brain's spontaneous electrical activity along the scalp and it can be used to measure voltage fluctuations which result from ionic current flows within neurons found in the brain.The electroencephalogram is increasingly used to measure anesthetic drug effect on the central nervous system.The use of electroencephalographic monitors has been proven to decrease drug consumption during anesthesia and to lead to a faster recovery from anesthesia. Recently, the use of the Bispectral Index® (BIS®) monitor (Aspect Medical Systems, Newton, MA) has been shown to decrease the incidence of intraoperative awareness. Depth of anesthesia is frequently assessed using electroencephalogram processing systems, such as BIS and M-Entropy® (Datex-Ohmeda, Helsinki, Finland). The use of these monitors has been claimed to allow more accurate drug administration which has the theoretical benefit of avoiding phases of too light or too profound anesthesia and the associated risks of hemodynamic instability. Inadequate general anesthesia caused by under dosage causes intraoperative awareness whereas prolonged anesthesia increases the risk of postoperative complications because of over dosage. The most important factor that contributes to the inadequate general anesthesia is the current limited ability to determine the level of awareness. In this study, the investigators want to analyze the raw EEG waves under general anesthesia using sevoflurane of MAC 1.0 for different age groups from 0 to 80 years old. The relation between concentration of 1.0 MAC sevoflurane and raw EEG states in different age groups is relatively unstudied. In this prospective randomized study the investigators want to know if there is any correlation of brain waves under general anesthesia in different age groups. Given that the brain rapidly develops and undergoes significant changes from childbirth into adulthood, anesthesia induced EEG oscillations in children might differ from those of adults, and could vary significantly with age. Characterizing the structure of the EEG in relation to age would help establish the foundations for age-appropriate monitoring of brain states during general anesthesia and sedation in children. The investigators aimed to examine the effects of age on the EEG during general anesthesia, with sevoflurane as the sole hypnotic agent.
After arrival in the operating room, an intravenous line will be inserted into a large forearm vein, and standard monitors will be applied. Each patient will be continuously monitored by a 3-lead electrocardiogram, noninvasive arterial pressure, pulse oximetry, and end-tidal carbon dioxide concentration.
The induction of anesthesia will be the same in all age groups and will consist of sufentanil 0.2-0.3mcg/kg or fentanyl 1-2 mcg/kg before intubation and 0.2 mg/kg cisatracurium to facilitate intubation. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration. After tracheal intubation, patients will be ventilated with a tidal volume of 6-8 ml/kg and the respiratory rate will be adapted to obtain an end-tidal carbon dioxide concentration of 30-35 mmHg.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Sevoflurane Inhal SolnInfant period: 1 month-1 year old |
| Group 2 | – | Drug: Sevoflurane Inhal SolnToddler period:1-3 years old |
| Group 3 | – | Drug: Sevoflurane Inhal SolnPreschool age period:3-6 years old |
| Group 4 | – | Drug: Sevoflurane Inhal SolnSchool age period:7-18 years old |
| Group 5 | – | Drug: Sevoflurane Inhal SolnAdults:18-65 years old |
| Group 6 | – | Drug: Sevoflurane Inhal SolnElderly:65-80 years old |
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 120 patients undergoing minor elective surgeries will be allocated in 6 age groups: 0-1 year old (infant period), 1-3 years old (toddler period), 3-6 years old (preschool age period), 7-18 years old (school age period), 18-65 years old (adults) and 65-80 years old (elderly).
Key inclusion criteria (2 listed)
- Patients age between 0 to 80 years old
- American Society of Anesthesiologists (ASA) I or II scheduled for minor surgeries under general anesthesia lasting less than 2 hours each.
Key exclusion criteria (6 listed)
- Potential subjects with any neurological or psychiatric disease
- Relative or absolute contraindication to sevoflurane including pregnancy by patient self-report
- Any recent prescription or illicit medication use will be excluded
- Patients with a history of any disabling central nervous or cerebrovascular disease
- Patients who had received central nervous system-active drugs
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 |
|---|---|---|
| Sevoflurane Inhal SolnAnesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Electroencephalography among various ages.
Time frame: The experiment will be carried out for 10 mins after induction of anesthesia and before beginning of the surgery.
Monitoring the raw EEG changes among various ages. The raw EEG waves of each patient will be analyzed and the results will be compared among the groups. The investigators want to see if there is any difference of the EEG wave among the 6 groups under 1.0 MAC sevoflurane.
1 secondary outcome
Morphology of electroencephalogram during 1.0 (MAC) Minimum Alveolar Concentration sevoflurane
Time frame: While the raw EEG wave is being recorded for a period of 10 mins, the investigators will adjust the concentration of sevoflurane bringing it to 1.0 MAC.
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 20 Sep 2018.
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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?
An observational study of Anesthesia, run by Second Affiliated Hospital of Wenzhou Medical University 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 2 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 20 Sep 2018. 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.
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?
Electroencephalography among various ages. (time frame: The experiment will be carried out for 10 mins after induction of anesthesia and before beginning of the surgery.). 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 20 Sep 2018.