Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence

NCT04291820 | Unknown DMC

• 1 other identifier: KDAR SUP 2020
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative emergence delirium (ED) is a severe postoperative complication in paediatric anaesthesia. ED is defined as a state with psychomotor disturbance, perception disorder and state of excitation and anxiety. The incidence of ED in paediatric patients can be up to 80%. ED is associated with the increased morbidity of paediatric patients in the postoperative period. One of the potential triggers of ED is sevoflurane. Currently, there are only limited data about comparing the influence of anesthesiologic management on the ED incidence. The possible ED reduction could lead to reduced stay in a post-anaesthesia care unit (PACU), postoperative nausea and vomiting (PONV) incidence and the overall reduction of the postoperative adverse events incidence together with the higher satisfaction and the patients and the legal guardians.

Conditions

Emergence Delirium

Keywords

Delirium; Emergence delirium; Paediatric patient; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence delirium incidence

  The incidence of emergence delirium based on PAED score

  postoperative period, up to 1 hour postoperatively

Secondary Outcomes (3)

• Time to first oral intake

  postoperative period, up to 1 hour postoperatively

• Adverse events incidence

  postoperative period, up to 1 hour postoperatively

• The need for concomitant medication in PACU

  postoperative period, up to 1 hour postoperatively

Study Arms (2)

Intravenous induction with desflurane maintenance

EXPERIMENTAL

The EMLA patch will be removed, and intravenous induction with propofol + opioid will be performed. The anaesthesia will be maintained with desflurane according to the levels of Bispectral index (BIS). Neuromuscular blockade is optional based on operator decision.

Procedure: Intravenous induction and desflurane anaesthesia maintenance

Inhalation induction with sevoflurane,sevoflurane maintenance

ACTIVE COMPARATOR

The EMLA patch will be removed, and inhalation induction with the sevoflurane will be performed. After peripheral vein cannulation, the opioid will be administered. The neuromuscular blockade is optional based on operator decision. Anaesthesia will be maintained with sevoflurane according to the set BIS levels.

Procedure: Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane

Interventions

Intravenous induction and desflurane anaesthesia maintenance PROCEDURE

Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels

Intravenous induction with desflurane maintenance

Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane PROCEDURE

Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels

Inhalation induction with sevoflurane,sevoflurane maintenance

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 2-10 years
• signed informed consent
• paediatric patient for elective adenoidectomy, or adenoidectomy with micro-otoscopy and/or frenulum discission

You may not qualify if:

• allergy and hypersensitivity on local anaesthetics in EMLA patch, general anaesthetics, or soya beans or peanuts
• venepuncture refusal · neuromuscular disorder with the contraindication of inhalation anaesthetics

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Petr Stourac, assoc.Prof.MD.Ph.D

CONTACT

5 3223 4261; stourac.petr@fnbrno.cz

Jozef Klučka, MD

CONTACT

532234696; Klucka.jozef@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants will be blinded by the arm inclusion. The outcomes will be measured by the blinded nurse in the PACU
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A prospective interventional single-blind randomized trial

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CZ (1)