The PREVENT AGITATION Trial II - Children ≤1 Year

Inclusion Criteria: * Paediatric patients (male and female), aged 3- ≤ 12 months * Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional * The legally acceptable representative for the study participant provides written informed consent/assent for the trial Exclusion Criteria: * ASA \>2 * Cardiac, neuro and trauma surgery * Ex-premature (\<37 weeks) • Premedication with clonidine * Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure * Critical illness incl. hemodynamic instability (inotropic drugs needed) * Bleeding requiring transfusion prior to scheduled anaesthesia * Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid * Malignant disease * Cardiac disease incl. arrhythmia * Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient * Mental retardation * Neurological disease including symptoms similar to emergence agitation * Has or is suspected of having a family or personal history of malignant hyperthermia * Has or is suspected of having an allergy to study treatment or its excipients * Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data * Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)