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临床试验/NCT03460509
NCT03460509Unknown4 期

A Randomized Double Blind Trial Comparing Reversal With Low Doses Of Sugammadex aFter Rocuronium-induced Neuromuscular Block Under General Anesthesia in Patients Undergoing Non-cardiac Surgery(TOF TRIAL)

The Hospital of Vestfold0 个研究点目标入组 144 人开始时间: 2018年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
144
主要终点
The time from study drug administration to reaching a TOF ratio of 0.9.

研究概览

简要总结

Neuromuscular blocking agents (NMBA) are among the most commonly used drugs during general anesthesia and may induce complete muscle paralysis.They are used clinically to facilitate endotracheal intubation and to optimize surgical working conditions. Incomplete recovery from non-depolarising NMBAs continues to be a common problem in modern postoperative care unit and is associated with significant risk of microaspiration and hypoventilation which leads to pulmonary complications.Recently effective reversal of neuromuscular blockade has been described by use of lower dose of sugammadex the recommended without providing adequate answer to whether the lower dose is safe enough to avoid recurrent block.

Hypotheses:

  1. Administration of sugammadex 0.25 mg/kg at TOF ratio 0.3 will successfully reverse (TOF=0.9) rocuronium induced neuromuscular block within 10 min.
  2. Recurrent block (TOF ratio < 0.9) does not occur after reversal with low dose sugammadex 0.25 mg/kg.

The primary objective of this trial is to assess the dose-response characteristics of sugammadex in reversing rocuronium induced neuromuscular block and to identify the minimal effective dose

Secondary objective is to assess the safety of different doses of sugammadex (recurrent block (TOF ratio < 0.9) after reversal and the occurrence of adverse reactions)

Sugammadex is a very expensive drug which limits its use i anaesthesia department. By optimising drug dosage it may have economic impact and contribute to a wider use of sugammadex to reverse neuromuscular block before extubation and thus avoid incomplete recovery. This may lead to less risk for postoperative pulmonary complications and thereby reduce morbidity and mortality after surgery.

详细描述

Doses of study drug will be 0 mg/kg Ideal Body Weight (IBW), 0.25 mg/kg IBW, 0.50 mg/kg IBW, 1.0 mg/kg IBW and 2.0 mg/kg IBW. TOF will be measured every 10th second until full reversal.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient, both genders, undergoing any elective in-hospital surgical procedure under general anesthesia requiring rocuronium neuromuscular block.
  • Signed informed consent

排除标准

  • Patient less than 18 years of age
  • Patient participating in another clinical study which could interfere with TOF trial.
  • Patient with neuromuscular disease
  • Patient from ICU
  • BMI > 30.0 kg/m2
  • Patient scheduled for local or regional anesthesia only
  • Patient undergoing general anesthesia without rocuronium
  • Patient with hypersensitivity to NMBAs or sugammadex. Also hypersensitivity to any active substance or to any of the following excipient: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections .
  • Renal dysfunction (GFR<30 mL/min/1,73m2)
  • Hepatic dysfunction
  • Patient who have received sugammadex in the last 24 h.
  • Pregnant or breastfeeding woman. Women in childbearing age must have a negative pregnant test before inclusion.
  • Bradycardia (puls <40)
  • Hypotension (Systolic BP <90 mmHg)

研究组 & 干预措施

Sugammadex 0 mg/kg

Placebo Comparator

Placebo NaCl 0,9%

干预措施: Sugammadex (Drug)

Sugammadex 0,25 mg/kg

Active Comparator

Sugammadex 0.25 mg/kg IBW

干预措施: Sugammadex (Drug)

Sugammadex 0,5 mg/kg

Active Comparator

Sugammadex 0.50 mg/kg IBW

干预措施: Sugammadex (Drug)

Sugammadex 1mg/kg

Active Comparator

Sugammadex 1.0 mg/kg IBW

干预措施: Sugammadex (Drug)

Sugammadex 2mg/kg

Active Comparator

Sugammadex 2 mg/kg IBW

干预措施: Sugammadex (Drug)

结局指标

主要结局

The time from study drug administration to reaching a TOF ratio of 0.9.

时间窗: 10 minutes

次要结局

  • Number of patient with reoccurrence of neuromuscular block after initial reversal to TOF ratio 0.9.(20 minutes)
  • Number of patients with adverse reactions in each group(until discharge - 3 days)

研究者

发起方
The Hospital of Vestfold
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tayyba Aslam

Principal investigator

The Hospital of Vestfold

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