2024-517057-27-00招募中3 期
(MOTOR Study) Neuromuscular MOniTOring in pediatric anesthesia. Randomized clinical study
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia
研究概览
简要总结
The main objective of the study is to analyze the frequency of sugammadex use, with and without the aid of quantitative neuromuscular monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children > 2 years or ≤ 16 years
- •Children who will undergo surgery in general anesthesia with tracheal intubation and receiving a non-depolarizing blockade agent,
- •Acquisition of informed consent by both legally recognized representatives, capable of understanding the document and providing consent on behalf of the participant.
排除标准
- •Children ≤ 2 years or > 16 years of age
- •Biliary tract and hepatic impairment, defined as levels of AST or ALT 3 times above the upper limit of the range of normality, or levels of total bilirubin 2 times above the upper limit of the range of normality, as reported by the local lab
- •Cardiac surgery
- •Emergency surgery
- •Known hypersensitivity to any of the study drugs or to any of their components, or to any component of the study drugs
- •Pregnancy or potential pregnancy
- •Any specific contraindication to any aspect of the protocol
- •Children with an ASA classification ≥ 3
- •Presence of neuromuscular disease, channelopathy, peripheral neuropathy or any clinical condition that could alter the neuromuscular function
- •Presence of contraindications to or impossible use of the TetraGraph monitoring: patients too small for the TetraSens Pediatric, skin lesions or tattoos in or in proximity of all the possible sites of the TetraSens Pediatric, implanted electronic device (such as a cardiac pacemaker), combined intraoperative use of short wave or microwave, epileptic patients, amputations or limb malformations.
- •Confirmed or suspected hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents or sugammadex
- •Conditions may affect the pharmacokinetics and/or pharmacodynamics of rocuronium bromide (biliary tract/hepatic/renal impairment, prolonged circulation time such as cardiovascular disease or edematous state, obesity, hypothermia, burn patients, severe electrolyte disturbances, altered blood pH or severe dehydration)
- •Confirmed or suspected contraindication to sugammadex (hypersensitivity to sugammadex or to any of the excipients)
- •Conditions may affect the pharmacokinetics and/or pharmacodynamics of sugammadex (increased risk of bleeding such as hereditary deficiencies of vitamin K-dependent coagulation factors, pre-existing coagulopathies. anticoagulants, renal and hepatic dysfunction, prolonged circulation time such as cardiovascular disease or edematous state, drugs such as Toremifene, EV fusidic acid, Hormonal contraceptives
- •Renal impairment, defined as GFR < 60 mL/min/1.73 m2, as calculated with Schwartz formula (eGFR = 0.5 × height (cm)/plasma creatinine)
结局指标
主要结局
The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia
The primary endpoint is the percentage of Sugammadex use in each arm at the end of anesthesia
次要结局
- The time needed to extubate patients
- the difference in the dose of sugammadex (mg/kg) in the two arms
- The frequency of respiratory complications during and after extubation (residual paralysis, upper airway obstruction, laryngospasm, bronchospasm)
- The best dose needed to reach the reversal of the neuromuscular blockade, indirectly evaluated from the need to administer further doses of sugammadex after extubation
- Possible adverse reactions to the use of sugammadex or to the use of TetraGraph System
- The incidence of extubation with residual neuromuscular paralysis (TOFr < 0.9)
- Quality of awakening and occurrence of any episodes of agitation/delirium (Richmond Agitation-Sedation Scale -RASS)
- The reliability of using quantitative neuromuscular monitoring in pediatrics, in the anesthetist's opinion
- The incidence of SpO2 < 90% in the post-operative acute care unit (PACU)
- The frequency of sugammadex use in patients with TOFr ≥ 0.9
研究者
Nicola Disma
Scientific
IRCCS Istituto Giannina Gaslini
研究点 (1)
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