Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence

NCT ID: NCT04291820

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-31

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.

Detailed Description

This prospective randomized interventional single-blind study aims to compare the influence of the anaesthesiology management no the incidence of ED in the postoperative period in paediatric patients. Elective paediatric patients (2-10 years) scheduled for the planned adenoidectomy or adenoidectomy + micro-otoscopy/adenoidectomy + frenulum linguae discission will be included in the trial after signed informed consent form the legal guardian. In all patients, the 2 Eutectic Mixture of Local Anesthetics (EMLA) patch will be applied on the predefined skin area ( visible vein for venepuncture) between 45 minutes to 60 minutes before anaesthesia. The patients will be randomized at the operating theatre (allocation 1:1) into the experimental group (intravenous induction with propofol + opioid and anaesthesia maintenance according to this set bispectral index value with desflurane) and the control group (inhalation induction with sevoflurane mixed with air and oxygen and anaesthesia maintenance with sevoflurane). The primary aim of the study will be the incidence of ED defined by The Pediatric Anesthesia Emergence Delirium (PAED) scale, which will be measured at the , at the admission to PACU and in the 5th, 10th, 15th, 30th minute and at the moment of dismission from PACU. The secondary aim will be the time to oral intake (from the end of the surgery), the incidence of adverse events (PONV, bradycardia, hypotension), the need for concomitant medication (analgesic medication, sedative medication, antiemetic medication).

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intravenous induction with desflurane maintenance

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.

Group Type: EXPERIMENTAL

Intravenous induction and desflurane anaesthesia maintenance

Intervention Type: PROCEDURE

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

Inhalation induction with sevoflurane,sevoflurane maintenance

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.

Group Type: ACTIVE_COMPARATOR

Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane

Intervention Type: PROCEDURE

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

Interventions

Intravenous induction and desflurane anaesthesia maintenance

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

Intervention Type: PROCEDURE

Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brno University Hospital

Brno, South Moravian, Czechia

Countries

Czechia

Central Contacts

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

Role: CONTACT

stourac.petr@fnbrno.cz

5 3223 4261 ext. 00420

Jozef Klučka, MD

Role: CONTACT

Klucka.jozef@fnbrno.cz

532234696 ext. 00420

Other Identifiers

KDAR SUP 2020

Identifier Type: -

Identifier Source: org_study_id