TO STUDY THE EFFECT OF NEUROMUSCULAR TRANSMISSION MONITORING (TOF) ON THE REQUIREMENT OF MUSCLE RELAXANT AND RECOVERY IN PATIENTS UNDERGOING GENERAL ANAESTHESIA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study the effect of neuromuscular transmission monitoring (train of four) on the requirement of muscle relaxant and recovery in patients undergoing general anaesthesia
研究概览
简要总结
Awide range of surgeries are done under general anaesthesia, and the maintenanceof muscle relaxation is important in facilitating surgical procedures.Neuromuscular blocking agents (NMBA),which are used in facilitation of intubation for general anaesthesia andmaintenance of muscle relaxation during the surgery, pose risk of residualparalysis. Residual paralysis (RP) after neuromuscular blockade (NMB) in therecovery room occurs in around 56.5% of patients, and it can increase theincidence of airway obstruction, hypoxaemia and postoperative pulmonarycomplications.
NeuromuscularTransmission monitoring (NMTM) is a means to determine the degree of NMB bystimulating a motor nerve with electriccurrent and observe the degree of contraction of the muscles innervated by thatnerve.It is used toevaluate the effect of NMBA. The muscleresponse after stimulation of its corresponding motor nerve is assessed. Themost frequently assessed nerve-muscle unit is the ulnar nerve and the adductorpollicis muscle.The muscle response can be evaluated either qualitatively orquantitatively. Qualitative (subjective) assessment is done with a peripheralnerve stimulator, where the observer evaluates the muscle response eithertactically or visually. Quantitative assessment is done with the monitor andthe response is objectively measured and displayed on a screen.Mechanomyography,electromyography and acceleromyography are such muscle response recordingmethods in quantitative monitoring. The types of stimuli used in NMTM aresingle stimulus, train of four (TOF) and post tetanic count (PTC).The TOFtechnique has remained the most useful method for assessing neuromuscularfunction for more than 40 years because it is simple and easy to assess. It isbased on the observation that increased stimulation frequency produces musclefatigue or fade. The proportion that results from dividing the fourth by thefirst evoked twitch (T4/T1) is the train-of-four ratio (TOFR). TOF has beenrecommended in clinical practice because it is the test that measuresneuromuscular function and is capable of providing information even when noprior value has been obtained. TOF count is an excellent guide considering that it reports not only thedegree of neuromuscular block but also the state of recovery from it.In most of the centers, the subjective assessment ofrecovery from the effect of a NMBA is done by observing eye‑opening,tongue protrusion, head lift and sustained hand grip for more than 5 seconds.
Our study wouldlike to evaluate the efficiency of the use of objective neuromusculartransmission monitoring by TOF when compared to subjective assessment inguiding the frequency of repeating the NMBAs during surgery and in assessingadequacy of reversal from NMBA at the time of recovery from generalanaesthesiaand in incidences of postoperative residual paralysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing general anaesthesia Patients under ASA I and II Age between 18 to 60 years.
- •Patients willing to sign the informed consent voluntarily.
排除标准
- •Pregnant females Patients with cognitive and mental disorders Patients with any neuromuscular disorders ASA III and above Patients with anticipated difficult intubation Surgery duration of more than 4 hours Surgeries in which either major blood loss/fluid shifts expected or occurs Surgeries of Head and neck Planned for awake extubations Patient in need of postsurgery intensive care admission Patient with body mass index >35 kg/m2 Patient with hepatic disease (liver enzyme value >50% normal value) Patient with renal insufficiency (serum creatinine>1.8 mg/dL) Patient with history of consumption of drugs known to affect neuromuscular transmission Any contraindications to neostigmine and/or atropine sulphate Patient with history of hypersensitivity or allergic to anaesthetic agent given Difficulty accessing the TOF measuring device in the ulnar nerve.
结局指标
主要结局
To study the effect of neuromuscular transmission monitoring (train of four) on the requirement of muscle relaxant and recovery in patients undergoing general anaesthesia
时间窗: 6 months
次要结局
- 1)To determine the total dose of muscle relaxant requirement for intubation(2)To determine the dose of intra-operative muscle relaxant requirement per hour)