Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06624696

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Respiratory Hypersensitivity Anticholinergics High Risk Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Inhalation Therapy; Complications Perioperative Respiratory Adverse Events Respiratory Tract Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.
  • Neuromuscular diseases.
  • Contraindication for PHC.
  • Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within 1 month before surgery.
  • Allergy to anticholinergic drugs.
  • Use of endotracheal tube (ETT) for ventilation.
  • Known difficult airway.
  • Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.
  • 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.
  • Parents refusing to allow their children to participate.
  • Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.

Treatment and study plan

Penehyclidine hydrochloride

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. The incidence of PRAEs

    Time frame: From beginning of anesthesia induction until the completion of postoperative recovery in PACU (including the phases of anesthesia induction, anesthesia maintenance, postoperative emergency and postoperative recovery), assessed up to 24 hours.

    PRAEs are subdivided into two types: major (bronchospasm and laryngospasm) and minor (severe coughing, breath holding, desaturation, upper airway obstruction, and stridor) events. The primary outcome is the incidence of PRAEs. Patients will be considered positive for respiratory adverse events if at least 1 of the above adverse events occurs.

Secondary outcomes

  1. The severity of major respiratory adverse events if occurs

    Time frame: From beginning of anesthesia induction until the completion of postoperative recovery in PACU (including the phases of anesthesia induction, anesthesia maintenance, postoperative emergency and postoperative recovery), assessed up to 24 hours.

    Major respiratory adverse events include laryngospasm and bronchospasm. Laryngospasm will be scored according to its severity as follows: 1=none, 2=partial-reposition airway, 3=partial-continuous positive airway pressure (CPAP), 4=complete-muscle relaxant. Bronchospasm will be scored according to its severity as follows: 1=none, 2= expiration only, 3= expiration and inspiration, 4=difficult to ventilate, require treatment.

  2. Ease of LMA insertion

    Time frame: From the beginning of LMA insertion until the completion of successful LMA insertion, assessed up to 24 hours

    This outcome includes time to successful insertion, the number of insertion attempts, and difficulty at insertion.

  3. The episode and degree of salivation during removal of LMA

    Time frame: At the time of LMA removal, assessed up to 24 hours

    Degree of salivation is evaluated as follows: 1=none; 2=minimal, no suction; 3=moderate, suction 1×; 4=copious, suction>1×.

  4. The airway hyperreactivity score

    Time frame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours

    This score is used to assessed severity of PRAEs, accounting for the intensity of coughing, breath holding, and oxygen desaturation on a scale ranging from 0 (none) to 4 (severe). The maximum score is 12, and a score of ≤3 is categorized as mild, 4 to 8 as moderate, and ≥9 as severe.

  5. The anesthesia-related time

    Time frame: During the phases of anesthesia emergence and recovery, assessed up to 24 hours

    The anesthesia-related time includes time to LMA removal, and PACU stay time.

  6. Emergence agitation

    Time frame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours

    Emergence agitation will be evaluated within stay in PACU using the Aono's four point scale (1: calm; 2: not calm but easily consolable; 3: not easily calmed restless or moderately agitated; 4: combative, disoriented, or excited). The scale scoring of 1 and 2 are considered as the absence of EA, and scale of 3 and 4 are considered as the presence of EA.

  7. Postoperative pain score

    Time frame: From the time of arrival in PACU until the time of discharge from PACU, assessed up to 24 hours

    Postoperative pain score will be assessed within stay in the PACU using the Wong-Baker Pain Scale. A score higher than 4 is defined as moderate-to-severe pain which need to be timely managed.

  8. The change of systolic blood pressure (SBP)

    Time frame: At baseline; 5 minutes after inhaling PHC; the completion of inhaling PHC; LMA insertion; upon arrival in PACU; pre-LMA mask removal; post-LMA mask removal; ready to discharge from PACU, assessed up to 24 hours

    The changes of SBP will be recorded.

  9. The change of heart rate (HR)

    Time frame: At baseline; 5 minutes after inhaling PHC; the completion of inhaling PHC; LMA insertion; upon arrival in PACU; pre-LMA mask removal; post-LMA mask removal; ready to discharge from PACU, assessed up to 24 hours

    The changes of HR will be recorded.

  10. The change of SpO2

    Time frame: At baseline; 5 minutes after inhaling PHC; the completion of inhaling PHC; LMA insertion; upon arrival in PACU; pre-LMA mask removal; post-LMA mask removal; ready to discharge from PACU, assessed up to 24 hours

    The change of SpO2 will be recorded.

  11. Other adverse events

    Time frame: From beginning of inhalation until the 24 postoperative hours.

    Other adverse events potentially related to inhale the study drug from beginning of inhalation until the 24 postoperative hours, including postoperative nausea and vomitting (PONV), dry month, palpation, dizziness, fever, cough, urine retention, and flushing.

  12. The incidence of respiratory infections within 7 days after surgery

    Time frame: Within 7 days after surgery.

    Children who develop respiratory infections within 7 days after surgery will be recorded during postoperative follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoliang Gan, PhD

CONTACT

[email protected]

86+13688893908

Yanling Zhu, MD

CONTACT

[email protected]

86+18898600243

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Shenzhen Eye Hospital

Registry information

Official study title

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

Acronym: PEPSI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.