Inhaling penehyclidine to reduce respiratory issues in children during surgery

Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia: a Double-blind, Randomized, Placebo-controlled Trial

This study is testing if inhaling a medication called penehyclidine can help young children aged 3 to 7 avoid breathing problems during and after minor eye surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 3 Years to 7 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06624696 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of inhaling penehyclidine hydrochloride to prevent perioperative respiratory adverse events (PRAEs) in pediatric patients aged 3 to 7 years who are at risk and scheduled for minor elective ophthalmic surgery. The study involves a randomized controlled design where participants will inhale either penehyclidine or normal saline prior to surgery. The aim is to determine if prophylactic inhalation of penehyclidine can lower the incidence of PRAEs in children with specific risk factors. The trial will assess the prevalence of respiratory complications post-anesthesia in the two groups.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to 7 years with at least one risk factor for PRAEs scheduled for ophthalmic surgery.

Not a fit: Patients with severe cardiopulmonary diseases or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce respiratory complications in high-risk pediatric patients undergoing anesthesia.

How similar studies have performed: Previous studies have indicated that inhalation therapies can reduce postoperative complications, suggesting potential success for this approach.

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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen Eye Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Xiaoliang Gan, PhD

Conditions Respiratory Hypersensitivity; Perioperative Respiratory Adverse Events; Anticholinergics; Inhalation Therapy; Complications; High Risk; perioperative respiratory adverse events; pediatric anesthesia