NL-OMON49696招募中4 期
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 - MK8616-169
Merck Sharp & Dohme (MSD)0 个研究点目标入组 11 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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
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 withi 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
研究者
相似试验
进行中（未招募）
1 期
PK, safety, and efficacy of sugammadex in children aged birth to <2 yearseuromuscular Blockade reversalMedDRA version: 21.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2017-000693-11-HUMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.126
进行中（未招募）
1 期
PK, safety, and efficacy of sugammadex in children aged birth to <2 yearseuromuscular Blockade reversalMedDRA version: 21.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2017-000693-11-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.126
进行中（未招募）
1 期
PK, safety, and efficacy of sugammadex in children aged birth to <2 yearseuromuscular Blockade reversalMedDRA version: 21.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2017-000693-11-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.126
进行中（未招募）
1 期
PK, safety, and efficacy of sugammadex in children aged birth to <2 yearsEUCTR2017-000693-11-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.126
进行中（未招募）
1 期
PK, safety, and efficacy of sugammadex in children aged birth to <2 yearseuromuscular Blockade reversalMedDRA version: 21.1Level: PTClassification code 10057286Term: Neuromuscular blockade reversalSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2017-000693-11-FIMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.126