Clinical trial NCT04291820: Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergence Delirium
Keywords: Delirium
Emergence delirium
Paediatric patient
Anaesthesia
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective interventional single-blind randomized trial
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Emergence delirium incidence
timeFrame: postoperative period, up to 1 hour postoperatively
Secondary outcomes:
measure: Time to first oral intake
timeFrame: postoperative period, up to 1 hour postoperatively
measure: Adverse events incidence
timeFrame: postoperative period, up to 1 hour postoperatively
measure: The need for concomitant medication in PACU
timeFrame: postoperative period, up to 1 hour postoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
References: