Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane
NCT ID: NCT03559504
Last Updated: 2018-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
120 participants
OBSERVATIONAL
2018-02-01
2018-09-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The EEG Study Under Sevoflurane Anesthesia in Children
NCT06580028
General Anesthetics-related Changes in Prefrontal EEG During Pediatric Surgical Anesthesia
NCT05210764
The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics
NCT03588429
The Effect of Ketamine on the WAVCNS Index During General Anesthesia: A Feasibility Study
NCT02908945
Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old
NCT05148065
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Infant period: 1 month-1 year old
Sevoflurane Inhal Soln
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
Group 2
Toddler period:1-3 years old
Sevoflurane Inhal Soln
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
Group 3
Preschool age period:3-6 years old
Sevoflurane Inhal Soln
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
Group 4
School age period:7-18 years old
Sevoflurane Inhal Soln
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
Group 5
Adults:18-65 years old
Sevoflurane Inhal Soln
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
Group 6
Elderly:65-80 years old
Sevoflurane Inhal Soln
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sevoflurane Inhal Soln
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anesthesiologists (ASA) I or II scheduled for minor surgeries under general anesthesia lasting less than 2 hours each.
Exclusion Criteria
* 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.
1 Month
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating 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, China
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAHoWMU-CR2017-03-216
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.