Emergence agitation MedDRA version: 20.1 Level: LLT Classification code 10079742 Term: Agitation on recovery from sedation System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Catapresan solution for injection 0.150 mg/ml
Product Name: Catapresan
Pharmaceutical Form: Injection
INN or Proposed INN: CLONIDINE
CAS Number: 4205-90-7
Concentration unit: µg/ml microgr
Sponsors
Copenhagen University Hospital, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Paediatric patients, age 3 = 12 months • Scheduled for 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 Are the trial subjects under 18? yes Number of subjects for this age range: 336 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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) • Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid • Bleeding requiring transfusion prior to scheduled anaesthesia • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the pharmacokinetic parameters of clonidine when administered as a single dose intraoperatively To evaluate the efficacy of clonidine for prevention of emergence agitation;Secondary Objective: To evaluate postoperative pain (opioid-sparring effect), postoperative nausea and vomiting in the postanaesthetic care unit. To evaluate a composite safety outcome of 1) clinically relevant hypotension AND clinically relevant bradycardia, 2) clinically relevant bradycardia AND clinically relevant apnoea.;Primary end point(s): Pharmacokinetic sampling will be conducted to estimate compartmental Clearance (CL), Volume of distribution (V) and T½ Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).;Timepoint(s) of evaluation of this end point: Pharmacokinetic end point will be evalutated from dosing to dicharge from the postanaethetic care unit (approx. 0-3 hours post dose) Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)The amount of additional opioid needed during stay in the postanaesthetic care unit (calculated as morphine equivalents) for treatment of postoperative pain 2)Postoperative nausea and vomiting: No validated scale for assessment of PONV exists and PONV will be assessed by nausea/vomiting Yes or No. 3)Composite safety outcome: The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea. 4)Safety -The number of patients experiencing adverse events -Prespecified events of clinical interest including: Clinically relevant hypotension, clinically relevant bradycardia, and clinically relevant apnoea -24-hour safety follow-up (telephone interview with parents or in-hospital visit, if child is admitted) and an additional 48-hour follow-up for patients with ongoing adverse events at the 24-hour safety follow-up -30-day follow-up in the National Patient Registry to assess any subsequent hospital admissions;Timepoint(s) of evaluation of this end point: 1)The amount of additional opioid needed during stay in the postanaesthetic care unit 2)Postoperative nausea and vomiting during stay in the postanaesthetic care unit. 3)Untill discharge from the postanaesthetic care unit 4) -During the study period -During the study period -Approximately 24 hours post dosing -30 days after dosing | — |
Countries
Denmark
Contacts
Public ContactDepartment of Anaesthesiology
Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed