Sugammadex Compared With Neostigmin/Atropin for Neuromuscular Block Reversal in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- TOF0.9 time
研究概览
简要总结
Incomplete recovery of neuromuscular function after surgery can lead to respiratory complications. Patients with obstructive sleep apnea (OSA) are prone to respiratory complications after surgery. Neostigmin and sugammadex are used for neuromuscular reversal.
The aim of this study was to compare sugammadex and neostigmin regarding efficacy, incidence of respiratory complications and cost in patients undergoing surgery for OSA
详细描述
This prospective double blind controlled study will be conducted after obtaining informed written patient consent.
Simple randomization will be accomplished with a computer-generated sequence of numbers and sealed envelopes will be used to allocate patients into 2 groups.
Group N will receive 50 µg kg-1 neostigmin,+05 mg atropin Group S will receive sugammadex 2mg kg-1 sugammadex at the and of surgery. Patients will enter the operation room without receiving premedication Heart rate, noninvasive blood pressures, body temperature, BIS, end-tidal respiratory gases and neuromuscular function (acceleromyography) will be monitored Propofol will be used for anesthesia induction Rocuronium 0.6 mg kg-1 will be used to facilitate intubation Anesthesia will be maintained with sevoflurane in oxygen and nitrous oxide, BIS will be maintainen between 40-60 Additional rocuronium doses will be administered when the TOF T2 is observed At the end of surgery, volatile anesthesia will be discontinued, the study drug will be administered according to group allocation and the TOF response at this time will be recorded Time to obtain TOF0.9 will be recorded Time to extubation, time to recovery, time spent in the operation room will be recorded Respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during anesthesia emergence will be recorded Patients will be transfered to the PACU, time spent in PACU and respiratory and cardiovascular complications (bradycardia, tachycardia, hypertention, ritmia, bronchospasm, laringospasm, breath holding, cough, desaturation, hypoxia, NIMV, reintubation) and treatments during PACU stay will be recorded After achieving an Aldrete score >9 patients will be transfered to the ward. Patients who can not achieve Aldrete score >9 after 1 hour will be transfered to the ICU.
Respiratory and cardiovascular complications and treatments in the ICU will be recored
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III Schedulled for surgery for obstructive sleep apnea -
排除标准
- •Neurouscular disorders hepatic or renal dysfunction allergy to study drugs using medication that could interfere with NMBAs pregnancy breasth feeding
研究组 & 干预措施
Sugammadex
Group S patients will receive 2 mg kg -1 sugammadex at the end of surgery
干预措施: Sugammadex (Drug)
Neostigmine
Group N patients will receive 50 µg kg-1 neostigmine and 05 mg atropin at the end of surgery
干预措施: Neostigmine (Drug)
结局指标
主要结局
TOF0.9 time
时间窗: postoperative 5 minutes
TOF 0.9 time will be recorded form the TOF watch after the study drug administration
次要结局
- desaturation(postoperative 5 minutes)
- bradycardia(postoperative 5 minutes)
- tachycardia(postoperative 5 minutes)
研究者
DILEK YAZICIOGLU
Dr
Diskapi Teaching and Research Hospital