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

NCT03559504 | Completed

• 1 other identifier: SAHoWMU-CR2017-03-216
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

electroencephalography; general anesthesia; sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (6)

Group 1

Infant period: 1 month-1 year old

Drug: Sevoflurane Inhal Soln

Group 2

Toddler period:1-3 years old

Drug: Sevoflurane Inhal Soln

Group 3

Preschool age period:3-6 years old

Drug: Sevoflurane Inhal Soln

Group 4

School age period:7-18 years old

Drug: Sevoflurane Inhal Soln

Group 5

Adults:18-65 years old

Drug: Sevoflurane Inhal Soln

Group 6

Elderly:65-80 years old

Drug: Sevoflurane Inhal Soln

Interventions

Sevoflurane Inhal Soln DRUG

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 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 1 Month - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: June 18, 2018
• Study Start: February 1, 2018
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

CN (1)