EUCTR2017-000693-11-FI进行中（未招募）1 期
A Phase 4 Double-blinded, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Is categorized as ASA Physical Status Class 1, 2, or 3 as determined by the investigator
- •2. Has a planned non-emergent surgical procedure or clinical situation (eg, intubation) that requires moderate or deep NMB with either rocuronium or vecuronium
- •3. Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring
- •4. Is male or female, between birth and <2 years of age at Visit 2
- •5. The legally acceptable representative for the study participant provides written informed consent/assent for the trial
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 126
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Is a preterm infant or neonate <36 weeks gestational age at birth
- •2. Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial
- •3. Has a neuromuscular disorder that may affect NMB and/or trial assessments
- •4. Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] <30 ml/min; using revised Schwartz estimate as method of calculation)
- •5. Has or is suspected of having a family or personal history of malignant hyperthermia
- •6. Has or is suspected of having an allergy to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
- •7. Is expected to require mechanical ventilation after the procedure
- •8. Has received or is planned to receive toremifene and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment
- •9. Use of medication expected to interfere with study treatments given in this trial, as per prescribing information. Rocuronium or vecuronium are concomitant medications to be used per label as adjunct to general anesthesia. Besides rocuronium or vecuronium, a participant must not be administered any other NMBA during the trial, including:
- •*Other steroidal NMBAs, such as pancuronium
- •*Nonsteroidal NMBAs such as succinylcholine or benzylisoquinolinium
- •compound (eg, cisatracurium). (Except in the circumstance that renewed muscle relaxation is needed after administration of study treatment, in which case a non-steroidal NMBA should be administered)
- •10. Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current trial.
- •11. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial
- •12. Is or has an immediate family member (eg, parent/legal guardian, or sibling) who is investigational site or Sponsor staff directly involved with this study
研究者
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