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RECRUITING
NCT06624696
PHASE4

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 7 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2024-11-12

Completion Date

2026-09-30

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Penehyclidine hydrochloride

The penehyclidine hydrochloride will be diluted to a total volume of 5 mL with normal saline, added to the nebulizer cup for inhalation. Patients will be asked to inhale the entire volume of nebulized drugs within 30 min prior to surgery. The trial drugs will be administered using a jet nebulizer with compressed air flow. Each child will be intructed to begin the nebulization by using a face mask that covers the nose and mouth while the child is seated upright. Children will be encouraged to take deep and slow breaths, inhaling through the mouth and exhaling through the nose, to ensure the drugs effectively reaches the airway.

DRUG

Normal Saline

The normal saline with a total volume of 5 mL will be added to the nebulizer cup for inhalation. Patients will be asked to inhale the entire volume of nebulized drugs within 30 min prior to surgery. The trial drugs will be administered using a jet nebulizer with compressed air flow. Each child will be intructed to begin the nebulization by using a face mask that covers the nose and mouth while the child is seated upright. Children will be encouraged to take deep and slow breaths, inhaling through the mouth and exhaling through the nose, to ensure the drugs effectively reaches the airway.

Locations (2)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Shenzhen Eye Hospital

Shenzhen, Guangdong, China