The Depth of Paediatric Anaesthesia: Observational Trial (ANAPED)

Perioperative measurement of the Depth of anaesthesia is currently recommended part of daily anaesthesia good clinical practice. The optimal depth of anaesthesia measured by Bispectral index could be between 40-60. The lower (over 60) depth of anaesthesia could be associated with accidental intraoperative episodes of awareness and deeper (below 40) anaesthesia could lead to higher adverse events or even haemodynamic instability.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Awareness
• Intervention / Treatment: Other: Anesthesia depth monitoring

Detailed Description

The hypothesis of the trial is that during the perioperative period serious fluctuations outside the recommended target depth of anaesthesia could occur. These fluctuations and the cumulative time spent in the shallow (over 60 BIS) or deep (under 40 BIS) could be associated with postoperative complications like emergence delirium (PAED over 10, and PAED over 12- 2 measurement methods), postoperative nausea and vomiting (PONV) and other postoperative complications (respiratory, hemodynamic).

Paediatric patients (between 1 year -19 years) undergoing elective general anaesthesia with presumed duration over 1 hour will be eligible for inclusion. The patients will be screened for eligibility during the preanaesthesia visit in the anaesthesiology examination room. After the Ethics committee and registration of the study at clinicaltrials.gov, the patients will be enrolled - according to the trial design. There is a presumption that informed consent won't be needed for participation due to observational trial. The anaesthesia induction will be performed either inhalation or intravenous route. After anaesthesia induction BIS monitor will be placed on the forehead according to the manufacturer recommendation and the anaesthesia team will be blinded to BIS monitor during the whole case. The initial BIS tracing will be recorded starting the surgery initiation (defined as the depth of anesthesia by the anaesthesiologist to initiate surgical intervention) and ending with end of surgical intervention. The incidence of periods outside the recommended anaesthesia depth will be recorded (episode is defined by ≥ 30 seconds interval outside the predefined limits, the end of episode is defined by the return to recommended BIS level). The cumulative time spent outside the recommended BIS levels will be evaluated as the primary outcome measure. The anaesthesiologist's ability to respond to fluctuations defined as YES / NO response, type of intervention and latency of the anaesthesiologist's response to fluctuation will be evaluated. The BIS recording will be terminated at the time the surgical intervention is finished. After surgery/anaesthesia, the patient will be transferred to ICU or post-anaesthesia care unit (PACU), where the incidence of emergence delirium (defined by PEAD score over 10 and over 12 - according to 2 measurement methods) and the incidence of PONV will be recorded. Also, cumulative incidence of overall complication in the postoperative period (desaturation, the need for oxygen therapy, haemodynamic instability, arrhythmias (over 150/min, below 50/min, allergic reactions) will be recorded. In the case of a critical BIS value (≥90, ≤10), blinding will be interrupted due to patient safety and the value will be notified to the anesthesiology team and the event will be recorded as a critical event.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jozef Klučka, assoc.prof.MD., Ph.D.; Phone Number: +420 532234696; Email: klucka.jozef@fnbrno.cz
• Study Contact Backup: Name: Tereza Musilová, MD; Phone Number: +420 532234691; Email: musilova.tereza@fnrbno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Recruiting
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients (between 1 year -19 years) undergoing elective general anaesthesia with presumed duration over 1 hour will be eligible for inclusion.

Description

Inclusion Criteria:

• Age 1 year-19 years
• Elective general anaesthesia with presumed duration over 60 minutes
• BIS monitor available

Exclusion Criteria:

• Outside the age limits
• Acute surgery
• Presumed anaesthesia duration below 1 hour
• Without the possibility of BIS monitoring
• Patient indicated for sedation and mechanical ventilation after anesthesia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Paediatric patients scheduled for general anesthesia; Paediatric patients (between 1 year -19 years) undergoing elective general anaesthesia with presumed duration over 1 hour will be eligible for inclusion

Other: Anesthesia depth monitoring; BIS monitor will be placed on the forehead according to the manufacturer recommendation and the anaesthesia team will be blinded to BIS monitor during the whole case. The initial BIS tracing will be recorded starting the surgery initiation (defined as the depth of anesthesia by the anaesthesiologist to initiate surgical intervention) and ending with end of surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative time outside recommended BIS levels	The cumulative time spent outside the recommended BIS levels will be evaluated	intraoperatively
Periods outside recommended BIS levels	The incidence of periods outside the recommended anaesthesia depth will be recorded (episode is defined by ≥ 30 seconds interval outside the predefined limits, the end of episode is defined by the return to recommended BIS level).	intraoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to respond	The anaesthesiologist's ability to respond to fluctuations defined as YES / NO response, type of intervention and latency of the anaesthesiologist's response to fluctuation will be evaluated.	Intraoperatively
Incidence of emergence delirium	After surgery/anaesthesia, the patient will be transferred to ICU or PACU, where the incidence of emergence delirium (defined by PEAD over 10 and over 12 - 2 measurement methods) and the incidence of PONV will be recorded.	2 hours postoperatively
Incidence of overall complications	Cumulative incidence of overall complication in the postoperative period (desaturation, the need for oxygen therapy, haemodynamic instability, arrhythmias (over 150/min, below 50/min, allergic reactions) will be recorded.	2 hours postoperatively
Delay to respond	Latency of the anaesthesiologist's response to fluctuation - defined in seconds from the onset of fluctuation to the end of fluctuation = return to the recommended BIS level	Intraoperatively
Incidence of postoperative nausea and vomiting (PONV(	Incidence of PONV at PACU	2 hours postoperatively

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Children; Pediatric; Anesthesia; Awareness
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Intraoperative Awareness; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: KDAR ANADEPTH 2022

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