A Phase 4 interventional study of Penehyclidine hydrochloride and Normal Saline in Respiratory Hypersensitivity, Perioperative Respiratory Adverse Events and Anticholinergics, sponsored by Sun Yat-sen University. Recruiting at 2 sites in China. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Inhaling penehyclidine hydrochloride (a dose of 0.05 mg/kg, diluted and mixed with normal saline to a total volume of 5 ml) for nebulization therapy within 30 min prior to surgery.
Drug: Penehyclidine hydrochloride
Inhaling normal saline in a total volume of 5 ml for nebulization therapy within 30 min prior to surgery.
Drug: Normal Saline
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.
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.
The incidence of PRAEs
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.
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.
The severity of major respiratory adverse events if occurs
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.
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.
Ease of LMA insertion
This outcome includes time to successful insertion, the number of insertion attempts, and difficulty at insertion.
Time frame: From the beginning of LMA insertion until the completion of successful LMA insertion, assessed up to 24 hours
The episode and degree of salivation during removal of LMA
Degree of salivation is evaluated as follows: 1=none; 2=minimal, no suction; 3=moderate, suction 1×; 4=copious, suction\>1×.
Time frame: At the time of LMA removal, assessed up to 24 hours
The airway hyperreactivity score
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.
Time frame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours
The anesthesia-related time
The anesthesia-related time includes time to LMA removal, and PACU stay time.
Time frame: During the phases of anesthesia emergence and recovery, assessed up to 24 hours
Emergence agitation
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.
Time frame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours
Postoperative pain score
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.
Time frame: From the time of arrival in PACU until the time of discharge from PACU, assessed up to 24 hours
The change of systolic blood pressure (SBP)
The changes of SBP will be recorded.
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 heart rate (HR)
The changes of HR will be recorded.
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
The change of SpO2 will be recorded.
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
Other adverse events
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.
Time frame: From beginning of inhalation until the 24 postoperative hours.
The incidence of respiratory infections within 7 days after surgery
Children who develop respiratory infections within 7 days after surgery will be recorded during postoperative follow-up.
Time frame: Within 7 days after surgery.
Plan to share: No
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Sun Yat-sen University