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临床试验/NCT04868409
NCT04868409已完成4 期

A Single Blinded Multicenter Randomized Study Comparing Intubating Conditions During Rapid Sequence Induction With Either Suxamethonium 1.0 mg/kg or Rocuronium 1.0 mg/kg in Elderly Patients (≥ 80 Years Old)

Matias Vested4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年8月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
102
试验地点
4
主要终点
Intubation conditions

研究概览

简要总结

The aim of this study is to determine the proportion of excellent tracheal intubation conditions at 60 seconds after administration of either rocuronium 1.0 mg/kg or suxamethonium 1 mg/kg in patients with age ≥ 80 years during rapid sequence induction.

详细描述

Elderly patients are frail and susceptible to complications in the perioperative period. They are at higher risk of major morbidity and mortality and are characterized by a reduction in cardiac output, liver function and renal function. These physiological changes influence pharmacodynamics and pharmacokinetics of drugs administered during anesthesia as for example neuromuscular blocking agents (NMBA).

The number of elderly patients (>80 years) is increasing and a large proportion of these patients will require surgery and anesthesia with employment of rapid sequence induction (RSI) within the next decades. RSI and intubation is performed when there is an increased risk of pulmonary aspiration of gastric contents. Because of its fast onset time succinylcholine is often used to facilitate tracheal intubation during RSI. However, succinylcholine has certain side effects such as cardiac arrhythmia, hyperkalemia, muscle soreness, short duration of action and shorter time to desaturation.

It is therefore unknown if succinylcholine 1.0 mg/kg provides better intubating conditions compared to high dose rocuronium (1.0 mg/kg) in the elderly. In this matter, there remains a need for a study to investigate the optimal muscle relaxant during rapid sequence induction for facilitating tracheal intubation in the elderly.

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)

入排标准

年龄范围
80 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for surgery under general anesthesia with indication for rapid sequence induction
  • American Society of Anesthesiologists physical status classification (ASA) I to IV
  • Informed consent (see appendix 1)
  • Body mass index (BMI) < 35 kg/m2
  • Read and understand Danish

排除标准

  • Neuromuscular disease
  • Known allergy to rocuronium and/or suxamethonium
  • Known hyperkalemia > 5 mM
  • Previous malignant hyperthermia
  • Known homozygote plasmacholinesterase gene mutation variant a or s
  • Known impaired kidney function defined as estimated glomerular filtration rate (eGFR) < 30

研究组 & 干预措施

Rocuronium group

Active Comparator

Rocuronium 1 mg/kg

干预措施: Rocuronium (Drug)

Suxamethonium group

Active Comparator

Suxamethonium 1 mg/kg

干预措施: Suxamethonium (Drug)

结局指标

主要结局

Intubation conditions

时间窗: 60 seconds after induction of anaesthesia

Tracheal intubating conditions according to the Fuchs-Buder scale: Excellent, good or poor depending on laryngoscopy, vocal chords and reaction to intubation,

次要结局

  • Time to TOF count 0(within 15 minutes)
  • Desaturation(within 15 minutes)
  • Time to tracheal intubation(within 15 minutes after administration of muscle relaxant)
  • cardiac arrythmia(within 15 minutes of anesthesia)
  • First pas succes rate(within 15 minutes)
  • Intubation conditions(within 15 minutes)
  • sore throat(24 hours after anaesthesia)
  • muscle soreness(24 hours after anaesthesia)

研究者

发起方
Matias Vested
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matias Vested

MD PhD

Rigshospitalet, Denmark

研究点 (4)

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