Antwerp University Hospital
Edegem, Antwerp, 2650, Belgium
NCT Number: NCT05308108
Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.
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Notify Me1 year–18 year
All sexes
Observational
Edegem, Antwerp, 2650, Belgium
Postoperative respiratory complications (PORC) may occur in children with obstructive sleep apnea undergoing upper airway surgery. The incidence of these postoperative respiratory complications can be affected by co-morbidities such as obesity, Down-syndrome, neurologic conditions, craniofacial malformation. Despite treatment guidelines from different scientific groups such as 'American Academy of Pediatrics', the 'European Respiratory Society' , the American Academy of Otorhinolaryngology and the American society of Anesthesiology, there is no consensus on the monitoring requirements and management of PORC in these children.
Further studies are required to investigate the role of age and OSAS severity on the occurence of PORC. Secondly, it would be interesting to develop a flowchart for the postoperative management of children with OSAS undergoing upper airway surgery, taking into account child-related factors such as age, OSAS and comorbidity.
As standard of care, all children are seen at the preoperative outpatient clinic by an anesthesiologist. If necessary, additional tests are performed with respect to the health condition of the child.
If all inclusion criteria are fulfilled and there are no exclusion criteria, Informed Consent will be asked of the accompanying parent or legal guardian.
Premedication is typically not indicated by these interventions because they are of short duration. In exceptional situations (for example an extremely anxious child) the use of premedication can be considered. In such a case, one can choose either midazolam sirup (Ozalin 0.25milligrams/kilogram (mg/kg) for children, 1 year or older, with a body weight of 3 to 40 kg) or Lorazepam sublingually (Temesta expidet) from an age of 6 years, dosage 0.5 mg for body weight of 25-50kg and dosage of 1 mg for body weight of 50 kg and more).
Per-operative anesthetic management: basic monitoring includes Electrocardiogram, non-invasive blood pressure monitoring, pulse oximetry, end-tidal carbon dioxide (EtCO2) and body temperature, intravenous (IV) access with administration of IV fluids as per body weight as standard of care. At the start of the intervention, venous access is obtained during inhalational anesthesia.
Drug-induced sleep endoscopy (DISE) is performed with IV propofol and/or sevoflurane. Induction of anesthesia occurs with IV propofol or inhalational anesthesia with sevoflurane. If propofol IV is used, a bolus of 10-20 mg and continuous infusion 6-10 mg/kg/hr is administered.
After the DISE examination, the child is intubated with fentanyl 2 micrograms/kg or sufentanil 0.2 micrograms/kg according to the clinical presentation. For neuromuscular block, atracurium 0.2 to 0.3 mg per kg is used. For maintenance of anesthesia a minimum alveolar concentration (MAC) 1 to 1.5 sevoflurane is kept.
Postoperative pain management is achieved by a combination of analgesics (non-steroidal anti-inflammatory drugs and paracetamol) as per age-specific indications (IV paracetamol 20mg/kg, ketorolac 0.5 mg/kg and morfine 0.05 mg/kg in cases of tonsillectomy) Postoperative nausea and vomiting is prevented by a single shot dexamethasone 0.15 milligram/kilogram IV.
After surgery, when the patient is awake he or she will be extubated and transferred to the Post Anesthetic Care Unit (PACU or recovery room) for monitoring of vital signs. Minimal requirement in the recovery room is a peripheral saturation monitor.
Monitoring of postoperative respiratory complications starts at end of surgery. So if a child develops respiratory problems upon awakening from anesthesia but before admission to the recovery room, these will also be registered as postoperative respiratory complications. Possible PORC are: laryngospasm, bronchospasm, desaturation requiring Oxygen, pulmonary edema.
In case of occurrence of PORC, the following interventions will be applied per protocol:
When the clinical parameters are stable for 30 minutes, at any time of the study protocol, the registration period for the study ends. Further management according to the responsible physician.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
registration of PORC in children with OSAS after (adeno)tonsillectomy
Time frame: 24hr postoperative period
Number of PORC
Time frame: 24 hr postoperative period
Number of PORC
Time frame: 2 years
Flowchart
University Hospital, Antwerp
Other
Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.
Acronym: PORC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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