Measuring Upper Airway Cross Sectional Areas During Residual Neuromuscular Blockade and After Reserval
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
- 否
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
Tamas Vegh, MD
Head, Division of General, Vascular and Thoracic Anesthesia
University of Debrecen
