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

Sun Yat-sen University

Status and phase: Enrolling; Phase 4

Conditions: Respiratory Hypersensitivity; High Risk; Anticholinergics; Perioperative Respiratory Adverse Events; Inhalation Therapy; Complications

Treatments: Drug: Normal Saline; Drug: Penehyclidine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06624696

IIT2024111

Details and patient eligibility

About

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.

Full description

Children with high risk factors of perioperative respiratory adverse events (PRAEs) remains a challenge for general anesthesia, inhalation of penehyclidine hydrochloride (PHC) has been showed to reduce postoperative pulmonary complications and enhance the recovery in high-risk surgical patients. Thus, prophylactic PHC inhalation might show promising benefits against PRAEs in pediatric anesthesia. This clinical study is designed to test the hypothesis that pediatric patients who exist at least 1 risk factor of PRAEs prophylactically to inhale PHC have a lower prevalence of PRAEs.

Enrollment: 204 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups, including a placebo group

The penehyclidine hydrochloride group

Experimental group

Description:

Inhaling penehyclidine hydrochloride (a dose of 0.05 mg/kg, diluted and mixed with normal saline to a total volume of 5 ml) for nebulization therapy within 30 min prior to surgery.

Treatment:

Drug: Penehyclidine hydrochloride

The normal saline group

Placebo Comparator group

Description:

Inhaling normal saline in a total volume of 5 ml for nebulization therapy within 30 min prior to surgery.

Treatment:

Drug: Normal Saline