Clinical trial NCT06624696: Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia
Official title: Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia: a Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Respiratory Hypersensitivity
Perioperative Respiratory Adverse Events
Anticholinergics
Inhalation Therapy; Complications
High Risk
Keywords: perioperative respiratory adverse events
pediatric anesthesia
penehyclidine
sevoflurane
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Eye Hospital
First posted: 2024-10-03
Enrollment: 204
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients aged 3 to 7 years.
2. Scheduled to undergo ophthalmic surgery.
3. 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:

1. American Society of Anesthesiologists (ASA) physical classification ≥ IV.
2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).
3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);
4. Neurological disorders.
5. Neuromuscular diseases.
6. Contraindication for PHC.
7. Inhalation of β2-receptor activator, M-receptor blockers and/or glucocorticoids within 1 month before surgery.
8. Allergy to anticholinergic drugs.
9. Use of endotracheal tube (ETT) for ventilation.
10. Known difficult airway.
11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.
12. 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.
13. Parents refusing to allow their children to participate.
14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.

Primary outcomes:
measure: The incidence of PRAEs
timeFrame: 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.
Secondary outcomes:
measure: The severity of major respiratory adverse events if occurs
timeFrame: 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.
measure: Ease of LMA insertion
timeFrame: From the beginning of LMA insertion until the completion of successful LMA insertion, assessed up to 24 hours
measure: The episode and degree of salivation during removal of LMA
timeFrame: At the time of LMA removal, assessed up to 24 hours
measure: The airway hyperreactivity score
timeFrame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours
measure: The anesthesia-related time
timeFrame: During the phases of anesthesia emergence and recovery, assessed up to 24 hours
measure: Emergence agitation
timeFrame: From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours
measure: Postoperative pain score
timeFrame: From the time of arrival in PACU until the time of discharge from PACU, assessed up to 24 hours
measure: The change of systolic blood pressure (SBP)
timeFrame: 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
measure: The change of heart rate (HR)
timeFrame: 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
measure: The change of SpO2
timeFrame: 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
measure: Other adverse events
timeFrame: From beginning of inhalation until the 24 postoperative hours.
measure: The incidence of respiratory infections within 7 days after surgery
timeFrame: Within 7 days after surgery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
state: Guangdong
Study officials:
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