Incidence of Emergence Delirium in the PACU

Study Overview
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Brief Summary
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Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period. The potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.

Detailed Description
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After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after general anaesthesia, in the Departement of paediatric anaesthesia and intensive care unit, University Hospital Brno in the term from 1.9.2020 until 30.6.2021 will be measured. Paediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.

Official Title
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Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

Conditions
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Emergence Delirium

Intervention / Treatment
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* Diagnostic Test: PAED measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021. Exclusion Criteria: Patients in the age from 0 to 1 month.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at PACU<br>Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery | Diagnostic Test: PAED measurement<br>* The incidence of emergence delirium, defined as PAED score above 10 points minimally in one of the PAED score measurements. PAED score will be measured in 0., 5., 10., 15., and 20. minute after PACU admission.<br>* Other names: PAED score measurement at PACU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of emergence delirium | The incidence of emergence delirium, defined as PAED score above 10 points and/or WATCHA score over 2 and or RASS over 1 minimally in one of the measurements. All measurements will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. The first measurement (T0) will be intiated after first obtaining RASS over -2. | up to 60 minutes after PACU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of ED | The cumulative duration of ED will be measured | up to 60 minutes after PACU admission | 
| The average PAED score | The average PAED score at PACU will be measured | up to 60 minutes after PACU admission | 
| The need for pharmacology intervention incidence | The need for pharmacology intervention - defined by the number of therapeutic interventions | up to 60 minutes after PACU admission | 
| incidence of postoperative nausea and vomiting (PONV) | incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics | up to 60 minutes after PACU admission | 
| type of anaesthesia induction (inhalation vs. intravenous) | type of anaesthesia induction (inhalation vs. intravenous) will be evaluated | up to 60 minutes after PACU admission | 
| type of anaesthesia (TIVA, combined, inhalational) | type of anaesthesia (TIVA, combined, inhalational) will be evaluated | up to 60 minutes after PACU admission | 
| length of the surgery | length of the surgery will be evaluated | up to 60 minutes after PACU admission | 
| type of the surgery | type of the surgery will be evaluated | up to 60 minutes after PACU admission | 
| cumulative dose of administered sedatives | the cumulative dose of administered sedatives | up to 60 minutes after PACU admission | 
| The average WATCHA score | The average WATCHA score at PACU will be measured | up to 60 minutes after PACU admission | 
| The average RASS score | The average RASS score at PACU will be measured | up to 60 minutes after PACU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence delirium, Anaesthesia, Paediatric patient