Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence

Emergence Delirium Clinical Trial

— AnaPed  

Official title:

Anaesthesiology Management and the Impact on Emergenece Delirium Incidence in Paediatric Patients Undergoing Adenoidectomy or Adenoidectomy With Frenulum Dicsision a/or Microotoscopy: Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04291820
• Other study ID #: KDAR SUP 2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Petr Stourac, assoc.Prof.MD.Ph.D
• Phone: 5 3223 4261
• Email: stourac.petr[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Procedure:
• Intravenous induction and desflurane anaesthesia maintenance
Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels
• Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane
Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergence delirium incidence	The incidence of emergence delirium based on PAED score	postoperative period, up to 1 hour postoperatively
Secondary	Time to first oral intake	The interval between the end of surgery and first oral intake will be measured	postoperative period, up to 1 hour postoperatively
Secondary	Adverse events incidence	The adverse events in the postoperative period will be evaluated - postoperative nausea and vomiting, bradycardia, hypotension, anxiety	postoperative period, up to 1 hour postoperatively
Secondary	The need for concomitant medication in PACU	The need for concomitant medication in PACU - analgesic, sedative, antiemetic medication	postoperative period, up to 1 hour postoperatively