Clinical trial NCT04091724: Perioperative EEG-Monitoring and Emergence Delirium in Children
Official title: Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 400
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children for elective surgery aged under 16 years

Brief summary: Emergence delirium is a significant problem, particularly in children. However the incidence, preventative strategies, and management of emergence delirium remain unclear. Multichannel electroencephalogram is a recognized tool for identifying neurophysiologic states during anesthesia, sleep, and arousal. The aim of the current study is to evaluate the mechanisms and predictors of emergence delirium in children under 16 years scheduled for elective surgery using electroencephalogram. The "Pediatric Anesthesia Emergence Delirium Scores (PAED Score)" (Sikich et al. 2004) is used to screen for the occurrence of emergence delirium in the post anesthesia care unit.


Eligibility criteria: Inclusion Criteria:

1. male or female children aged under 16 years
2. planned elective surgery
3. informed consent by parents or legal guardians

Exclusion Criteria:

1. history of neurological or psychiatric disease
2. delayed development
3. inability of the parents or legal guardians to speak or read Chinese
4. participation in another prospective interventional clinical study during this study

Primary outcomes:
measure: Incidence of emergence delirium
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary outcomes:
measure: Relative power of each brain waves
timeFrame: from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours
measure: Preoperative anxiety of children
timeFrame: baseline (At the preoperative holding room)
measure: Compliance of the children during induction
timeFrame: Procedure (At the beginning of the Induction)
measure: Blood pressure
timeFrame: During the operation, an average of 1 hour
measure: Heart rate
timeFrame: During the operation, an average of 1 hour
measure: Body temperature
timeFrame: During the operation, an average of 1 hour
measure: Duration of anesthesia
timeFrame: During the anesthesia, an average of 1 hour
measure: Type of surgery
timeFrame: During the operation
measure: Duration of surgery
timeFrame: During the operation, an average of 1 hour
measure: Number of Participants with adverse events
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour
measure: The level of consciousness
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
measure: Postoperative pain: FLACC- Scale
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
measure: Severity of emergence Delirium
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
measure: Duration of emergence Delirium
timeFrame: Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
measure: Post-Anesthesia Care Unit (PACU) stay time
timeFrame: During the stay in the Post-Anesthesia Care Unit, an average of 1 hour
measure: Incidence of behavioral problem
timeFrame: Up to 30 postoperative days
measure: Number of Participants with postoperative organ complications
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 days.
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an average of 5 days.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
citation: Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
citation: Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
citation: Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. doi: 10.1097/00000542-199811000-00015.
citation: Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
citation: Stargatt R, Davidson AJ, Huang GH, Czarnecki C, Gibson MA, Stewart SA, Jamsen K. A cohort study of the incidence and risk factors for negative behavior changes in children after general anesthesia. Paediatr Anaesth. 2006 Aug;16(8):846-59. doi: 10.1111/j.1460-9592.2006.01869.x.
citation: Kerson AG, DeMaria R, Mauer E, Joyce C, Gerber LM, Greenwald BM, Silver G, Traube C. Validity of the Richmond Agitation-Sedation Scale (RASS) in critically ill children. J Intensive Care. 2016 Oct 26;4:65. doi: 10.1186/s40560-016-0189-5. eCollection 2016.