NCT06624696 Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia
| NCT ID | NCT06624696 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sun Yat-sen University |
| Condition | Respiratory Hypersensitivity |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 204 participants in total. It began in 2024-11-12 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled study is to evaluate the effectiveness of inhaling penehyclidine hydrochloride in reducing perioperative respiratory adverse events in children at risk undergoing minor elective surgery.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06624696 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 7 Years, studying Respiratory Hypersensitivity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06624696 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06624696 currently recruiting?
Yes, NCT06624696 is actively recruiting participants. Contact the research team at ganxl@mail.sysu.edu.cn for enrollment information.
Where is the NCT06624696 trial being conducted?
This trial is being conducted at Guangzhou, China, Shenzhen, China.
Who is sponsoring the NCT06624696 clinical trial?
NCT06624696 is sponsored by Sun Yat-sen University. The trial plans to enroll 204 participants.