RecruitingPhase 4NCT06624696

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

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

Sponsor

Sun Yat-sen University

Enrollment

204 participants

Start Date

Nov 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 3 YearsMax Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Normal Saline and a drug called Penehyclidine hydrochloride for people with anticholinergics, high-risk, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 3 Years to 7 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPenehyclidine 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.

DRUGNormal 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.