Skip to main content
OpenTrials
Completed

NCT Number: NCT04531020

Incidence of Emergence Delirium in the PACU

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 month–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brno

Brno, Česká Republika, 62500, Czechia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAED measurement

Diagnostic Test

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.

Other names: PAED score measurement at PACU

Primary outcomes

  1. The incidence of emergence delirium

    Time frame: up to 60 minutes after PACU admission

    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.

Secondary outcomes

  1. The duration of ED

    Time frame: up to 60 minutes after PACU admission

    The cumulative duration of ED will be measured

  2. The average PAED score

    Time frame: up to 60 minutes after PACU admission

    The average PAED score at PACU will be measured

  3. The need for pharmacology intervention incidence

    Time frame: up to 60 minutes after PACU admission

    The need for pharmacology intervention - defined by the number of therapeutic interventions

  4. incidence of postoperative nausea and vomiting (PONV)

    Time frame: up to 60 minutes after PACU admission

    incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics

  5. type of anaesthesia induction (inhalation vs. intravenous)

    Time frame: up to 60 minutes after PACU admission

    type of anaesthesia induction (inhalation vs. intravenous) will be evaluated

  6. type of anaesthesia (TIVA, combined, inhalational)

    Time frame: up to 60 minutes after PACU admission

    type of anaesthesia (TIVA, combined, inhalational) will be evaluated

  7. length of the surgery

    Time frame: up to 60 minutes after PACU admission

    length of the surgery will be evaluated

  8. type of the surgery

    Time frame: up to 60 minutes after PACU admission

    type of the surgery will be evaluated

  9. cumulative dose of administered sedatives

    Time frame: up to 60 minutes after PACU admission

    the cumulative dose of administered sedatives

  10. The average WATCHA score

    Time frame: up to 60 minutes after PACU admission

    The average WATCHA score at PACU will be measured

  11. The average RASS score

    Time frame: up to 60 minutes after PACU admission

    The average RASS score at PACU will be measured

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

Acronym: PACUDEL

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2020
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.