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临床试验/NCT06544980
NCT06544980招募中不适用

Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval

Tamas Vegh, MD1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values

研究概览

简要总结

In our study, the investigators sought to answer the question of how the retroglossal pharyngeal areas measured after extubation of patients compare to baseline (before muscle relaxation) values. The investigators also investigated how these areas change as a function of TOF ratios measured at extubation, thus looking for a correlation between residual muscle relaxant effect and airway area.

详细描述

Introduction

Postoperative residual neuromuscular can cause severe respiratory complications. One of these is pharyngeal dilator muscle weakness, which can lead to airway obstruction. One way to prevent this is to have objective neuromuscular monitors to track the degree of muscle relaxation and use the measurements to guide the the suspension of neuromuscular block. Monitoring the muscle relaxant effect is not a mandatory component of anaesthesia and is therefore often omitted in anaesthesiologists. In our study, the investigators investigated whether, at the end of surgery, only patients extubated at the end of surgery, based on clinical signs, have an airway diameter reduction and how this relates to the degree of residual muscle relaxation. Our single-centre, prospective study included 20 patients. The patients' narcosis by the anaesthetist, as is often done in routine anaesthesia work, is without monitoring neuromuscular block and on the basis of clinical signs deciding on extubation.

Sample size calculation

In a previous study, Eikermann and associates (Eikermann M, Vogt FM, Herbstreit F, Vahid-Dastgerdi M, Zenge MO, Ochterbeck C, de Greiff A, Peters J. The predisposition to inspiratory upper airway collapse during partial neuromuscular blockade. Am J Respir Crit Care Med. 2007;175(1):9-15.) using MRI technique described a minimal retroglossal diameter after a total neuromuscular recovery of 20.2±5.2 mm and a 20% decrease of this diameter at TOFR=0.8. the investigators hypothesised that in the present study, the decrease of the retroglossal cross-section area during inspiration will decrease by 30% in patients with residual neuromuscular block of any severity. Using and alpha of 0.05 and a power of 90%, 8 patients were calculated to be necessary to prove our hypothesis. In a previous study, it was found that in our working group the amount of residual neuromuscular block (as defined TOFR <90%) during spontaneous recovery at the end of surgery approximates 45% of all cases (Nemes R, Fülesdi B, Pongrácz A, Asztalos L, Szabó- Maák Z, Lengyel S, Tassonyi E. Impact of reversal strategies on the incidence of postoperative residual paralysis after rocuronium relaxation without neuromuscular monitoring: A partially randomised placebo controlled trial. Eur J Anaesthesiol. 2017;34(9):609-616.). With respect to this, the investigators planned to include 18 patients. the investigators also calculated with eventual dropouts and finally included 20 patients.

Procedure of the investigation

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-65 years;
  • BMI 18.5-25 (normal body weight);
  • men/women in equal proportion;
  • duration of surgeries at least ≥ 30 minutes;
  • intervention requiring intratracheal intubation;
  • patients are in a supine position.

排除标准

  • diseases affecting neuromuscular function (myopathies, severe liver and kidney failure);
  • drugs affecting neuromuscular function (magnesium, aminoglycosides);
  • difficult airway, expected difficult intubation;
  • pregnancy (pregnancy test for women of childbearing age to rule out pregnancy we finish);
  • breastfeeding;
  • acute surgery;

结局指标

主要结局

The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different TOF values

时间窗: before intubation, after extubation of the trachea

The differences in retroglossal pharyngeal cross sectional areas (inspiration and exspiration) measured at different train of four TOF values, and changes in these values compared to (initial) retroglossae pharyngeal areas detected before administration of muscle relaxants. Areas are measured in pixels and the rate of reduction of areas is expressed as a percentage.

次要结局

未报告次要终点

研究者

发起方
Tamas Vegh, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tamas Vegh, MD

Head, Division of General, Vascular and Thoracic Anesthesia

University of Debrecen

研究点 (1)

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