Incidence of Emergence Delirium in the PACU

Emergence Delirium Clinical Trial

— PACUDEL  

Official title:

Incidence of Emergence Delirium in the PACU: Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531020
• Other study ID #: KDAR FN Brno 2020/10
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1421
• Est. completion date: January 1, 2022
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: 1 Month to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

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.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno	Ceská Republika

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The duration of ED	The cumulative duration of ED will be measured	up to 60 minutes after PACU admission
Secondary	The average PAED score	The average PAED score at PACU will be measured	up to 60 minutes after PACU admission
Secondary	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
Secondary	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
Secondary	type of anaesthesia induction (inhalation vs. intravenous)	type of anaesthesia induction (inhalation vs. intravenous) will be evaluated	up to 60 minutes after PACU admission
Secondary	type of anaesthesia (TIVA, combined, inhalational)	type of anaesthesia (TIVA, combined, inhalational) will be evaluated	up to 60 minutes after PACU admission
Secondary	length of the surgery	length of the surgery will be evaluated	up to 60 minutes after PACU admission
Secondary	type of the surgery	type of the surgery will be evaluated	up to 60 minutes after PACU admission
Secondary	cumulative dose of administered sedatives	the cumulative dose of administered sedatives	up to 60 minutes after PACU admission
Secondary	The average WATCHA score	The average WATCHA score at PACU will be measured	up to 60 minutes after PACU admission
Secondary	The average RASS score	The average RASS score at PACU will be measured	up to 60 minutes after PACU admission