Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry
研究概览
简要总结
This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
- •Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and:
- •expected to undergo neuromuscular relaxation with rocuronium for
- •endotracheal intubation; and
- •expected to require at least one maintenance dose of rocuronium; and
- •expected to require active reversal of neuromuscular blockade; and
- •expected to require clinical or subjective neuromuscular monitoring only; and
- •expected to recover in the PACU
- •Arm that is accessible for measuring the TOF ratio in the PACU
- •Sexually active female patient of child-bearing potential must agree to use a
- •medically accepted method of contraception through seven days after receiving
- •protocol-specified medication.
排除标准
- •Anatomical malformations that may lead to difficult intubation
- •Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial assessments
- •Dialysis-dependent or has or is suspected of having severe renal insufficiency
- •Significant hepatic dysfunction
- •Family history of malignant hyperthermia
- •Cardiac pacemaker
- •Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
- •Toremifene before or within 24 hours of study drug administration
- •Scheduled for an overnight stay (or >12 hours) in PACU
- •Expected transfer to an Intensive Care Unit after surgery
- •Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy follow-up visit
- •Breast-feeding.
- •Investigational drug(s) within 30 days of randomization on this study
- •Participation in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
- •Participant or family member is among the personnel of the investigational or Sponsor staff directly involved with this trial
研究组 & 干预措施
Sugammadex
Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
干预措施: Sugammadex (Drug)
Neostigmine/glycopyrrolate
Participants receive neostigmine/glycopyrrolate per usual practice
干预措施: Neostigmine (Drug)
Neostigmine/glycopyrrolate
Participants receive neostigmine/glycopyrrolate per usual practice
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry
时间窗: At PACU entry on Day 1
Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.
次要结局
- Time From Start of Study Drug Administration to Operating Room Discharge-ready(Day 1)