The EEG Study Under Remimazolam Anesthesia in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
The effect of Remimazolam on brain electrical activity. Previous studies have shown that in healthy male volunteers, EEG changes during Remimazolam infusion are characterized by an initial increase in the beta band and a later increase in the delta band. When monitoring the depth of anesthesia, the commonly used Bispectral Index in clinical practice was originally developed for propofol. Therefore, studies have shown that the correlation between the depth of sedation of benzodiazepines such as midazolam and Bispectral Index is weak. In contrast, the beta wave ratio is considered a more suitable EEG indicator for monitoring the sedative effect of Remimazolam. The above indicates that Remimazolam has a specific pattern of influence on EEG activity, especially in the regulation of anesthesia depth, with unique characteristics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Congenital malformation or other genetic conditions that are thought to affect brain development ;
History of severe heart, brain, liver, kidney and metabolic diseases ;
Premature infants (≤32 weeks);
Upper respiratory tract infection in the last two weeks. -
Trial population
Children were aged 1 years-12 years; with American Society of Anesthesiologists (ASA) physical status I or II; and requiring general anesthesia under remimazolam;
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: 1-3 years
Group B: 4-6 years
Group C: 7-12 years
Trial outcomes
Primary outcomes
1
Time-frequency characteristics of electroencephalogram (EEG)
Time-frequency characteristics of electroencephalogram (EEG) in children of different ages during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery) .
Time frame
Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)Secondary outcomes
1
Modified observer's assessment of alertness/sedation (MOAA/S)
5#Subject responds readily to name spoken in a normal tone; 4 #Lethargic response of a subject to a name spoken in a normal tone; 3 #The subject responds only after a name is called loudly and repeatedly; 2 #The subject responds only after mild prodding or shaking; 1 #The subject responds only after a painful trapezius squeeze; 0 #The subject does not respond to painful trapezius squeeze. MOAA/S score ≤ 2 points represent successful sedation
Time frame
Intraoperative (during remimazolam general anesthesia (including anesthesia induction, maintenance and recovery)2
Recovery time
From the time sevoflurane was stopped until the child opened his eyes for the first time and reached an Aldrete score of ≥9
Time frame
Within up to 30 minutes after operation3
Pediatric anesthesia emergence delirium
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score.
Time frame
Within up to 30 minutes after operation4
The Face, Legs, Activity, Cry, Consolability Scale (FLACC)
The FLACC scale consists of five items. Each item is scored 0-2 yielding a total between 0 and 10. The degree of pain increased directly with the total score.
Time frame
Within up to 30 minutes after operationSponsors and contacts
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Source ClinicalTrials.gov