Incidence of Emergence Delirium in the PACU

Completed

• Conditions: Emergence Delirium
• Interventions: Diagnostic Test: PAED measurement

• Registration Number: NCT04531020
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-28
• Study Start: 2020-10-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1421

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients at PACU	PAED measurement	Patients undergoing elective surgical or diagnostic intervention admitted to PACU after postanaesthesia recovery

Primary Outcome Measures

Name	Time	Method
The incidence of emergence delirium	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 Outcome Measures

Name	Time	Method
The need for pharmacology intervention incidence	up to 60 minutes after PACU admission	The need for pharmacology intervention - defined by the number of therapeutic interventions
type of the surgery	up to 60 minutes after PACU admission	type of the surgery will be evaluated
The average WATCHA score	up to 60 minutes after PACU admission	The average WATCHA score at PACU will be measured
type of anaesthesia induction (inhalation vs. intravenous)	up to 60 minutes after PACU admission	type of anaesthesia induction (inhalation vs. intravenous) will be evaluated
The duration of ED	up to 60 minutes after PACU admission	The cumulative duration of ED will be measured
incidence of postoperative nausea and vomiting (PONV)	up to 60 minutes after PACU admission	incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics
length of the surgery	up to 60 minutes after PACU admission	length of the surgery will be evaluated
type of anaesthesia (TIVA, combined, inhalational)	up to 60 minutes after PACU admission	type of anaesthesia (TIVA, combined, inhalational) will be evaluated
cumulative dose of administered sedatives	up to 60 minutes after PACU admission	the cumulative dose of administered sedatives
The average PAED score	up to 60 minutes after PACU admission	The average PAED score at PACU will be measured
The average RASS score	up to 60 minutes after PACU admission	The average RASS score at PACU will be measured

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Česká Republika, Czechia