Actively Recruiting

Phase 4
Age: 3Years - 7Years
All Genders
NCT06624696

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

Led by Sun Yat-sen University · Updated on 2026-04-14

204

Participants Needed

2

Research Sites

98 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

S

Shenzhen Eye Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 3Years - 7Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged 3 to 7 years
  • Scheduled to undergo ophthalmic surgery
  • At risk of perioperative respiratory adverse events with at least one parent-reported risk factor such as recent cold, wheezing during exercise, frequent wheezing, nocturnal dry cough, eczema, family history of asthma or allergies, or exposure to passive smoke
Not Eligible

You will not qualify if you...

  • ASA physical classification of IV or higher
  • Known cardiopulmonary diseases like uncorrected heart defects, pulmonary hypertension, tumors, or lung structural diseases
  • Severe kidney or liver dysfunction (Child-Pugh grade C)
  • Neurological or neuromuscular disorders
  • Contraindications to penehyclidine hydrochloride
  • Inhalation of beta-2 receptor activators, M-receptor blockers, or glucocorticoids within 1 month before surgery
  • Allergy to anticholinergic drugs
  • Use of endotracheal tube for ventilation
  • Known difficult airway
  • Severe upper respiratory infections with surgery delay recommended
  • Participation in another clinical trial within the last month or six half-lives of the prior study drug
  • Parents refusing participation
  • Obesity with body mass index over the 95th percentile per WHO guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

Shenzhen Eye Hospital

Shenzhen, Guangdong, China, 518040

Actively Recruiting

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Research Team

X

Xiaoliang Gan, PhD

CONTACT

Y

Yanling Zhu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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