Skip to content

Incidence of Emergence Delirium in the PACU

Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04531020
Acronym
PACUDEL
Enrollment
1421
Registered
2020-08-28
Start date
2020-10-01
Completion date
2022-01-01
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

Emergence delirium, Anaesthesia, Paediatric patient

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.

Interventions

DIAGNOSTIC_TESTPAED measurement

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.

Sponsors

Brno University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 19 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of emergence deliriumup to 60 minutes after PACU admissionThe 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.

Secondary

MeasureTime frameDescription
The average PAED scoreup to 60 minutes after PACU admissionThe average PAED score at PACU will be measured
The need for pharmacology intervention incidenceup to 60 minutes after PACU admissionThe need for pharmacology intervention - defined by the number of therapeutic interventions
incidence of postoperative nausea and vomiting (PONV)up to 60 minutes after PACU admissionincidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics
type of anaesthesia induction (inhalation vs. intravenous)up to 60 minutes after PACU admissiontype of anaesthesia induction (inhalation vs. intravenous) will be evaluated
type of anaesthesia (TIVA, combined, inhalational)up to 60 minutes after PACU admissiontype of anaesthesia (TIVA, combined, inhalational) will be evaluated
The duration of EDup to 60 minutes after PACU admissionThe cumulative duration of ED will be measured
type of the surgeryup to 60 minutes after PACU admissiontype of the surgery will be evaluated
cumulative dose of administered sedativesup to 60 minutes after PACU admissionthe cumulative dose of administered sedatives
The average WATCHA scoreup to 60 minutes after PACU admissionThe average WATCHA score at PACU will be measured
The average RASS scoreup to 60 minutes after PACU admissionThe average RASS score at PACU will be measured
length of the surgeryup to 60 minutes after PACU admissionlength of the surgery will be evaluated

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026