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Trial record 45 of 658 for:    Sevoflurane

Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane

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ClinicalTrials.gov Identifier: NCT03559504
Recruitment Status : Completed
First Posted : June 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

Brief 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 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.

Condition or disease Intervention/treatment
Anesthesia Drug: Sevoflurane Inhal Soln

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.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparing EEG Patterns in Different Age Groups During General Anesthesia With Sevoflurane
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : September 5, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Group/Cohort Intervention/treatment
Group 1
Infant period: 1 month-1 year old
Drug: 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
Drug: 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
Drug: 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
Drug: 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
Drug: 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
Drug: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
    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.



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Ages Eligible for Study:   1 Month to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559504


Locations
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China, Zhejiang
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, 325027
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Second Affiliated Hospital of Wenzhou Medical University:
Study Protocol  [PDF] June 27, 2018
Statistical Analysis Plan  [PDF] June 27, 2018


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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03559504     History of Changes
Other Study ID Numbers: SAHoWMU-CR2017-03-216
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital of Wenzhou Medical University:
electroencephalography
general anesthesia
sevoflurane

Additional relevant MeSH terms:
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Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General