Association between Pre-operative frailty and Post Operative residual paralysis in elderly patients undergoing surgery under general anaesthesia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- the ratio of the handgrip strength at TOF count of 0.9 to the TFIO at baseline
研究概览
简要总结
Frailty is a common and morbid condition found with a higher prevalence in older adults beforesurgery (25%- 56%) than in community-dwelling elders (10%). Frailty has been conceptualizedin two major ways: one includes decreased reserve to physiologic stress and is characterized bydecline across organ systems; and the other is an accumulation of deficits, that is, the accumulationof comorbid states that can result in overall physiologic vulnerability. Frailty has been shown tocorrelate with poor postoperative outcomes (death, complications) in a wide rangeof majorsurgeries. A frailty screen that includes grip strength may not be best suited for a cervical spinepopulation that often has cervical myelopathy. The preoperative testing facility may dictate the typeof assessment possible; some preoperative clinic areas are not suitable for a 5-meter gait speed test.
Residual neuromuscular blockade is one of the most serious clinical problems in postoperativesettings. It may also lead to significant increases in respiratory morbidity and health-careutilization while putting patients at additional risk. Even though the availability of new drugs and new protocols should help us prevent residual neuromuscular blockade, its incidencehas not yet changed significantly.It is important that clinicians have information regarding variables that predict the duration ofaction of neuromuscular blocking drugs. The patient’s ability to raise and maintain the head for 5seconds, show the tongue, open the eyes, or cough, and adequate tidal ventilation are frequentlyused to predict postoperative muscle relaxant recovery. However, these assessments are oftennot performed correctly. In addition, the above tests do not solely exclude clinically significantresidual curarization after general anesthesia.
there are no studies on association between preoperative frailty and postoperativeresidualparalysis. Ultrasonography of diaphragmthickness may reveal residual effects of NMBAs in conscious patients
this study aims to determine the association between pre-operative frailty in elderly patients undergoing surgery under general anaesthesia with post-operative residualneuromuscular paralysis. the secondary objective is to determine the association between residual neuromuscular paralysis and increasedlength of hospital stay, increased length of ICU stay, increased requirement of postoperativemechanical ventilation, increased mortality.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age above 60 years 2.Undergoing surgery of duration from 1-3 hours 3.Can give informed consent themselves.
排除标准
- •1.Significant kidney disease (stage 4 kidney disease or higher).
- •2.Significant liver disease (Child-Pugh B or C class).
- •3.Allergic to neostigmine or sugammadex.
- •4.History of a neuromuscular disorder.
- •6.Pregnancy or nursing women.
- •7.Refusal to participate.
- •8.Arrhythmic disease or taking anti-arrhythmic drugs.
- •9.Inability to extubate at the end of surgery.
结局指标
主要结局
the ratio of the handgrip strength at TOF count of 0.9 to the TFIO at baseline
时间窗: 60 MINUTES
次要结局
- (1) the ratio of the handgrip strength, parasternal intercostal muscle, diaphragm excursion at the time of TOF 0.9, cTOFr 0.9 and 30 min after PACU admission to baseline, respectively; ((2) the recovery time from TOFr 0.9 to TOFr 0.95 and to unity, respectively.)