Perioperative EEG-Monitoring and Emergence Delirium in Children

Delirium Clinical Trial

Official title:

Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04091724
• Other study ID #: TJMZK201901
• Status: Recruiting
• Start date: December 2, 2019
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: Huazhong University of Science and Technology
• Contact: Hua Zheng, M.D.
• Phone: 0086-27-83663173
• Email: hzheng[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of emergence delirium	The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value = 10 is considered emergence delirium.	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Relative power of each brain waves	Electroencephalogram data were acquired using a 32-channel electroencephalogram recording system (Brain Products, Germany). A 5 min, baseline, eyes-closed recording was conducted at the preoperative holding room when the child was at rest. Recording of electroencephalogram was commenced before the start of anesthetic induction and was stopped before discharge of the child from the Post-Anesthesia Care Unit. We defied delta (1 to 3 Hz), theta (4 to 7 Hz), alpha (8 to 12 Hz), and beta (13 to 40 Hz) frequency bands. And then, the relative power of each frequency bands to the total power of the sum is calculated.	from stay at the preoperative holding room to discharge of the child from the Post-Anesthesia Care Unit, , an average of 3 hours
Secondary	Preoperative anxiety of children	Preoperative anxiety is evaluated using the preoperative modified Yale Preoperative Anxiety Scale (m-YPAS) score (Kain et al. 1997). The modified Yale Preoperative Anxiety Scale (m-YPAS) consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent). Children's behavior is rated from 1 to 4 or 1 to 6 (depending on the item), with higher numbers indicating the highest severity within that item. Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.	baseline (At the preoperative holding room)
Secondary	Compliance of the children during induction	Measured by Induction compliance checklist (Kain et al. 1998).	Procedure (At the beginning of the Induction)
Secondary	Blood pressure	Systolic and diastolic blood pressures are assessed.	During the operation, an average of 1 hour
Secondary	Heart rate		During the operation, an average of 1 hour
Secondary	Body temperature		During the operation, an average of 1 hour
Secondary	Duration of anesthesia		During the anesthesia, an average of 1 hour
Secondary	Type of surgery		During the operation
Secondary	Duration of surgery		During the operation, an average of 1 hour
Secondary	Number of Participants with adverse events	Adverse events such as vomiting, cough, breath holding, laryngospasm, and oxygen desaturation are recorded	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, , an average of 1 hour
Secondary	The level of consciousness	The level of consciousness is measured by Richmond Agitation Sedation Scale score (Kerson et al. 2016). The Richmond Agitation and Sedation Scale (RASS) is a 10-point scale, with four levels of anxiety or agitation, one level denoting a calm and alert state, and 5 levels of sedation.	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Postoperative pain: FLACC- Scale	Postoperative pain is measured by the FLACC- Scale (Merkel et al. 1997). The Face, Legs, Activity, Cry, Consolability (FLACC ) scale is a measurement used to assess pain for children or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Severity of emergence Delirium	The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value = 10 is considered emergence delirium.	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Duration of emergence Delirium	The Delirium is measured by the Pediatric Anesthesia Emergence Delirium Scores (PAED Score) (Sikich et al. 2004).The PAED scale is a validated observational measure of 5 aspects of child behavior (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to produce a total score ranging from 0 to 20; greater scores indicate greater severity. A peak PAED value = 10 is considered emergence delirium.	Recovery from anesthetic until discharge of the child from the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Post-Anesthesia Care Unit (PACU) stay time	When patients become calm and meet a modified Aldrete score (Aldrete et al. 1995) = 9, they are discharged and the duration of the PACU stay is recorded as the PACU stay time.	During the stay in the Post-Anesthesia Care Unit, an average of 1 hour
Secondary	Incidence of behavioral problem	The behavioral problem is measured by a modified Version of the Posthospital Behavior Questionnaire (PHBQ) (Stargatt et al. 2006)	Up to 30 postoperative days
Secondary	Number of Participants with postoperative organ complications		Participants will be followed for the duration of hospital stay, an average of 5 days.
Secondary	Hospital length of stay		Participants will be followed for the duration of hospital stay, an average of 5 days.