Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia

Launched by SUN YAT-SEN UNIVERSITY · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called penehyclidine, which is inhaled, to see if it can help prevent breathing problems in children who are at risk during minor eye surgeries. The focus is on children between 3 and 7 years old who have certain health factors that might put them at risk for these breathing issues, such as a recent cold, wheezing, or a family history of asthma.

Eligible children will be closely monitored during the trial, and their parents will be informed about what to expect throughout the process. It's important to note that children with serious health issues, such as severe heart or lung diseases, or certain allergies, will not be able to participate. The study is currently looking for participants, so if you think your child might qualify, you can discuss it with their doctor to learn more about joining the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Pediatric patients aged 3 to 7 years.
• • 2. Scheduled to undergo ophthalmic surgery.
• • 3. Judged to be at risk of PRAEs (with at least one parentally reported risk factor for the PRAEs, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke).
• Exclusion Criteria:
• • 1. American Society of Anesthesiologists (ASA) physical classification ≥ IV.
• • 2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).
• • 3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);
• • 4. Neurological disorders.
• • 5. Neuromuscular diseases.
• • 6. Contraindication for PHC.
• • 7. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within 1 month before surgery.
• • 8. Allergy to anticholinergic drugs.
• • 9. Use of endotracheal tube (ETT) for ventilation.
• • 10. Known difficult airway.
• • 11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.
• • 12. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.
• • 13. Parents refusing to allow their children to participate.
• • 14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.