Incidence of Emergence Delirium in the PACU (PACUDEL)

Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Diagnostic test: PAED measurement

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.

• Study Type: Observational
• Enrollment (Actual): 1421

Contacts and Locations

Study Locations

• Czechia
  • Česká Republika
    • Brno, Česká Republika, Czechia, 62500
      • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 19 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after general anaesthesia hospitalized in the PACU

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients at PACU; Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery	Diagnostic test: PAED 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.; Other Names: PAED score measurement at PACU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Anaesthesia; Emergence delirium; Paediatric patient
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: KDAR FN Brno 2020/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No