Incidence of Emergence Delirium in the PACU (PACUDEL)

• ClinicalTrials.gov Identifier: NCT04531020
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Last Update Posted: February 15, 2022
• Sponsor: Brno University Hospital
• Information provided by (Responsible Party): Petr Štourač, MD, Brno University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Emergence Delirium	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 Design

• Study Type: Observational
• Actual Enrollment: 1421 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Incidence of Emergence Delirium in the PACU: Prospective Observational Trial
• Actual Study Start Date: October 1, 2020
• Actual Primary Completion Date: June 30, 2021
• Actual Study Completion Date: January 1, 2022

Groups and Cohorts

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 Name: PAED score measurement at PACU

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. The duration of ED [ Time Frame: up to 60 minutes after PACU admission ]
   The cumulative duration of ED will be measured
2. The average PAED score [ Time Frame: up to 60 minutes after PACU admission ]
   The average PAED score at PACU will be measured
3. The need for pharmacology intervention incidence [ Time Frame: up to 60 minutes after PACU admission ]
   The need for pharmacology intervention - defined by the number of therapeutic interventions
4. incidence of postoperative nausea and vomiting (PONV) [ Time Frame: up to 60 minutes after PACU admission ]
   incidence of postoperative nausea and vomiting (PONV) defined by the cumulative dose of administered antiemetics
5. type of anaesthesia induction (inhalation vs. intravenous) [ Time Frame: up to 60 minutes after PACU admission ]
   type of anaesthesia induction (inhalation vs. intravenous) will be evaluated
6. type of anaesthesia (TIVA, combined, inhalational) [ Time Frame: up to 60 minutes after PACU admission ]
   type of anaesthesia (TIVA, combined, inhalational) will be evaluated
7. length of the surgery [ Time Frame: up to 60 minutes after PACU admission ]
   length of the surgery will be evaluated
8. type of the surgery [ Time Frame: up to 60 minutes after PACU admission ]
   type of the surgery will be evaluated
9. cumulative dose of administered sedatives [ Time Frame: up to 60 minutes after PACU admission ]
   the cumulative dose of administered sedatives
10. The average WATCHA score [ Time Frame: up to 60 minutes after PACU admission ]
    The average WATCHA score at PACU will be measured
11. The average RASS score [ Time Frame: up to 60 minutes after PACU admission ]
    The average RASS score at PACU will be measured

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients after general anaesthesia hospitalized in the PACU

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.

Contacts and Locations

Locations

Czechia

University Hospital Brno

Brno, Česká Republika, Czechia, 62500

Sponsors and Collaborators

Brno University Hospital

Investigators

• Study Chair: Petr Štourač, prof. MD., Ph.D.; Faculty of medicince Masaryk University and University Hospital Brno

More Information

• Responsible Party: Petr Štourač, MD, Clinical Professor, Brno University Hospital
• ClinicalTrials.gov Identifier: NCT04531020
• Other Study ID Numbers: KDAR FN Brno 2020/10
• First Posted: August 28, 2020
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Petr Štourač, MD, Brno University Hospital:

Emergence delirium; Anaesthesia; Paediatric patient

Additional relevant MeSH terms:

Delirium; Emergence Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes