Emergence Delirium Clinical Trial
— AnaPedOfficial 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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Brno University Hospital | Brno | South Moravian Region |
Lead Sponsor | Collaborator |
---|---|
Brno University Hospital |
Czechia,
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 |
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