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Clinical Trials/NCT04531020
NCT04531020
Completed
Not Applicable

Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

Brno University Hospital1 site in 1 country1,421 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
Brno University Hospital
Enrollment
1421
Locations
1
Primary Endpoint
The incidence of emergence delirium
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
January 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Brno University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Petr Štourač, MD

Clinical Professor

Brno University Hospital

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.

Outcomes

Primary Outcomes

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

  • type of anaesthesia (TIVA, combined, inhalational)(up to 60 minutes after PACU admission)
  • cumulative dose of administered sedatives(up to 60 minutes after PACU admission)
  • The average PAED score(up to 60 minutes after PACU admission)
  • The average RASS score(up to 60 minutes after PACU admission)
  • The need for pharmacology intervention incidence(up to 60 minutes after PACU admission)
  • type of the surgery(up to 60 minutes after PACU admission)
  • The average WATCHA score(up to 60 minutes after PACU admission)
  • type of anaesthesia induction (inhalation vs. intravenous)(up to 60 minutes after PACU admission)
  • The duration of ED(up to 60 minutes after PACU admission)
  • incidence of postoperative nausea and vomiting (PONV)(up to 60 minutes after PACU admission)
  • length of the surgery(up to 60 minutes after PACU admission)

Study Sites (1)

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