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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-7
SponsorSun Yat-sen University

About this trial

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 criteria

Qualifiers

Pediatric patients aged 3 to 7 years.

Scheduled to undergo ophthalmic surgery.

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).

Disqualifiers

American Society of Anesthesiologists (ASA) physical classification ≥ IV.

Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).

Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);

Neurological disorders.

Trial design

Treatments tested in this trial

  • Penehyclidine hydrochloride
  • Normal Saline

Treatment groups

204 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Sponsor institution

Shenzhen Eye Hospital

Collaborator