Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia: a Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- The incidence of PRAEs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
The normal saline group
Inhaling normal saline in a total volume of 5 ml for nebulization therapy within 30 min prior to surgery.
干预措施: Normal Saline (Drug)
The penehyclidine hydrochloride group
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.
干预措施: Penehyclidine hydrochloride (Drug)
结局指标
主要结局
The incidence of PRAEs
时间窗: 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.
次要结局
- The severity of major respiratory adverse events if occurs(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(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(At the time of LMA removal, assessed up to 24 hours)
- The airway hyperreactivity score(From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours)
- The anesthesia-related time(During the phases of anesthesia emergence and recovery, assessed up to 24 hours)
- Emergence agitation(From the time of LMA removal until regaining consciousness from anesthesia, assessed up to 24 hours)
- Postoperative pain score(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)(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)(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(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(From beginning of inhalation until the 24 postoperative hours.)
- The incidence of respiratory infections within 7 days after surgery(Within 7 days after surgery.)
研究者
Xiaoliang Gan
The head of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Zhongshan Ophthalmic Center, Sun Yat-sen University