The Reversal of Residual Neuromuscular Blockade After Neostigmine and Half-dose Sugammadex: A Comparison With Standard Reversal of Full-dose Neostigmine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 主要终点
- Recovery time-3
研究概览
简要总结
Sugammadex may prevent residual neuromuscular blockade by providing rapid reversal at the end of the operation. Our goal is to compare the half-dose use of sugammadex for reversing residual blockade after administration of neostigmine and atropine to the routine use of reversal medication.
详细描述
Background: Postoperative residual neuromuscular block (PONB) may be observed in patients in the recovery room after surgery, and this event causes significant adverse events such as respiratory muscle weakness, decreased tidal volumes causing hypoxemia, reintubation, prolonged mechanical ventilation, and possible risk for a cardiopulmonary arrest.
Goal: The study investigators hypothesized to investigate the effects of the half-dose use of sugammadex for reversing residual blockade after administration of neostigmine and atropine and compare these results to the routine full-dose use neostigmine and atropine.
The Study Design:
The study investigators planned to perform a prospective, single-blinded, randomized trial.
The study Protocol:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study protocol was masked to an outcomes assessor and the persons for this duty include an observer, a resident, or an anesthesia nurse during the anesthesia process but not to the care provider or the supervising physician.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •40 and 65 years of age,
- •American Society of Anesthesiologists Physical Status (ASA-PS) of 3 and 4,
- •Elective lower gastrointestinal tumor resection surgeries,
- •Supine positioning,
- •Surgery requiring use of general anesthesia and muscle relaxation,
- •Use of inhalational agent of sevoflurane anesthesia,
- •Surgical duration of about three to six hours.
排除标准
- •History of known or suspected neuromuscular disease,
- •History of renal or hepatic dysfunction,
- •Hyperkalemia,
- •Patients receiving antibiotics, anticonvulsants, or magnesium,
- •History of stroke,
- •History of glaucoma,
- •History of pregnancy or breastfeeding,
- •Suspicion of abdominal infection or sepsis,
- •Suspected history of malignant hyperthermia,
- •An allergy to medications used during general anesthesia
研究组 & 干预措施
Neostigmine
The Group N (Neostigmine) (n=48), patients received standard intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg doses before extubation.
A train-of-four (TOF) count of 2 in TOF Watch monitoring provides information of a shallow neuromuscular block. If at least two twitches are on the TOF watch monitor, the study investigators administer reversal medication for neuromuscular blockade in both groups. At this point, depending on randomization, a reversal agent is administered for each randomized group by an anesthesia resident or nurse who is blinded to the study protocol. The study investigators record the recovery periods between the start of administering the reversal agent to the recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9 if it occurs. These time periods are in minutes.
干预措施: Neostigmine (Drug)
Neostigmine and Sugammadex
In Group N+S (Neostigmine+Sugammadex) (n=50), patients received standard intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg doses before extubation. After a three-minute waiting period, the study investigators administered an intravenous bolus half-dose of 1 mg/kg of sugammadex after the standard reversal dose.
A train-of-four (TOF) count of 2 in TOF Watch monitoring provides information of a shallow neuromuscular block. If at least two twitches are on the TOF watch monitor, the study investigators administer reversal medication for neuromuscular blockade in both groups. At this point, depending on randomization, a reversal agent is administered for each randomized group by an anesthesia resident or nurse who is blinded to the study protocol. The study investigators record the recovery periods between the start of administering the reversal agent to the recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9 if it occurs. These time periods are in minutes.
干预措施: Sugammadex (Drug)
结局指标
主要结局
Recovery time-3
时间窗: After operation within 24 hours
The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio≥ 0.9
Muscle strength after extubation
时间窗: After operation within 24 hours
The clinical assessment of muscle strength in the operating room are as follows; awake status, The investigated parameters were; arousable with minimal stimulation, cooperativeness, responsive only to tactile stimulation, cooperativeness, and able to perform five-second head lift.
Recovery time-2
时间窗: After operation within 120 minutes
The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio \< 0.7
Incidence of postoperative residual neuromuscular blockade (rNMB)
时间窗: After operation within 24 hours
Incidence of postoperative residual neuromuscular blockade (rNMB) (defined as a train-of-four ratio, TOFR \<0.9) measured 15 min after administration of the reversal agent.
Recovery time-1
时间窗: After operation within 120 minutes
The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio \< 0.9 to 0.7
次要结局
- Time frame-1(After operation within 30 minutes)
- Time frame-2(After operation within 30 minutes)
- Time frame-4(After operation within 120 minutes)
- Aldrete Score greater than nine in the recovery room(After operation within 120 minutes)
- Rescue medication neostigmine(After operation within 120 minutes)
- Rescue medication sugammadex(After operation within 120 minutes)
- Adverse events-1(After operation within 24 hours)
- Adverse events-2(After operation within 24 hours)
- Time frame-3(After operation within 60 minutes)
研究者
Ayse Baysal
Associate Professor of Anesthesiology and Reanimation
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital