Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence
Keywords
Abstract
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).
Dates
Last Verified: | 05/31/2020 |
First Submitted: | 02/25/2020 |
Estimated Enrollment Submitted: | 02/27/2020 |
First Posted: | 03/01/2020 |
Last Update Submitted: | 06/02/2020 |
Last Update Posted: | 06/04/2020 |
Actual Study Start Date: | 12/31/2020 |
Estimated Primary Completion Date: | 12/30/2023 |
Estimated Study Completion Date: | 12/30/2023 |
Condition or disease
Intervention/treatment
Procedure: Intravenous induction with desflurane maintenance
Procedure: Inhalation induction with sevoflurane,sevoflurane maintenance
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: 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. | Procedure: Intravenous induction with desflurane maintenance Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels |
Active Comparator: 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. | Procedure: Inhalation induction with sevoflurane,sevoflurane maintenance Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels |
Eligibility Criteria
Ages Eligible for Study | 2 Years To 2 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. Emergence delirium incidence [postoperative period, up to 1 hour postoperatively]
Secondary Outcome Measures
1. Time to first oral intake [postoperative period, up to 1 hour postoperatively]
2. Adverse events incidence [postoperative period, up to 1 hour postoperatively]
3. The need for concomitant medication in PACU [postoperative period, up to 1 hour postoperatively]