Clinical trial NCT04531020: Incidence of Emergence Delirium in the PACU
Official title: Incidence of Emergence Delirium in the PACU: Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Delirium
Keywords: Emergence delirium
Anaesthesia
Paediatric patient
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 1421
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after general anaesthesia hospitalized in the PACU

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of emergence delirium
timeFrame: up to 60 minutes after PACU admission
Secondary outcomes:
measure: The duration of ED
timeFrame: up to 60 minutes after PACU admission
measure: The average PAED score
timeFrame: up to 60 minutes after PACU admission
measure: The need for pharmacology intervention incidence
timeFrame: up to 60 minutes after PACU admission
measure: incidence of postoperative nausea and vomiting (PONV)
timeFrame: up to 60 minutes after PACU admission
measure: type of anaesthesia induction (inhalation vs. intravenous)
timeFrame: up to 60 minutes after PACU admission
measure: type of anaesthesia (TIVA, combined, inhalational)
timeFrame: up to 60 minutes after PACU admission
measure: length of the surgery
timeFrame: up to 60 minutes after PACU admission
measure: type of the surgery
timeFrame: up to 60 minutes after PACU admission
measure: cumulative dose of administered sedatives
timeFrame: up to 60 minutes after PACU admission
measure: The average WATCHA score
timeFrame: up to 60 minutes after PACU admission
measure: The average RASS score
timeFrame: up to 60 minutes after PACU admission
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Česká Republika
Study officials:
affiliation: Faculty of medicince Masaryk University and University Hospital Brno
name: Petr Štourač, prof. MD., Ph.D.
role: STUDY_CHAIR
References: