Incidence of Emergence Delirium in the PACU

NCT04531020 | Completed DMC

• 1 other identifier: KDAR FN Brno 2020/10
• Study Type: observational
• Target: 1,421
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

Emergence delirium; Anaesthesia; Paediatric patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The duration of ED

  up to 60 minutes after PACU admission

• The average PAED score

  up to 60 minutes after PACU admission

• The need for pharmacology intervention incidence

  up to 60 minutes after PACU admission

• incidence of postoperative nausea and vomiting (PONV)

  up to 60 minutes after PACU admission

• type of anaesthesia induction (inhalation vs. intravenous)

  up to 60 minutes after PACU admission

Study Arms (1)

Patients at PACU

Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery

Diagnostic Test: PAED measurement

Interventions

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.

Also known as: PAED score measurement at PACU

Patients at PACU

Eligibility Criteria

• Age: 1 Month - 19 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients after general anaesthesia hospitalized in the PACU

You may qualify if:

• Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.

You may not qualify if:

• Patients in the age from 0 to 1 month.

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, Česká Republika, 62500, Czechia

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Petr Štourač, prof. MD., Ph.D.

  Faculty of medicince Masaryk University and University Hospital Brno

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: January 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CZ (1)