跳至主要内容
临床试验/CTRI/2016/10/007419
CTRI/2016/10/007419已完成不适用

EVALUATION OF INTUBATING CONDITIONS WITH ROCURONIUM 0.6 mg/Kg USING TRAIN OF FOUR STIMULATION IN ELECTIVE SURGERY

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2016年7月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Number of patients having excellent intubating conditions with rocuronium 0.6mg/Kg

研究概览

简要总结

Neuromuscularblockers (NMBs) are widely used in anaesthesia practice during endotrachealintubation. The degree of neuromuscular block is usually evaluated by clinicalcriteria. But the recommendation for application of neuromuscular monitoring topatients receiving NMBs is based on two important issues: first, on thevariable individual response to muscle relaxants and second because of thenarrow therapeutic window. Adequate muscle relaxation  for intubation corresponds to a narrow rangeof 90 to 95% receptor occupancy.1 Inadequate muscle relaxationduring intubation can lead to difficulty in securing the airway or multipleattempts leading to laryngeal morbidity like postoperative hoarseness (4-42%)and vocal cord injury.2

Rocuroniumis one of the most commonly used non depolarising muscle relaxant forintubation of the trachea. It has been postulated that laryngeal muscles beingresistant to the effects of neuromuscular blocking agents,3 requireat least twice the ED95 dose.4

Asit is difficult to quantify the relaxation of the laryngeal muscles, thereforesurrogates such as Adductor pollicis longus (APL), orbicularis oculi (OO),corrugator supercilii (CS)5 and even flexor hallucis brevis (FHB)6have been utilised, though APL is the preferred site. Neuromuscular transmissioncan be monitored by various methods like single twitch (ST), double burststimulation (DBS) and train of four (TOF). Although good clinical researchpractice (GCRP) states that either ST or TOF can be used as a guide forintubation, TOF is preferable because it is more sensitive to lesser degree ofreceptor occupancy than single twitch.1 Observation of evoked TOFresponses after a dose of non depolarising muscle relaxant allows prediction of onset time of paralysis oflaryngeal muscles  in individualpatients.

Inthe absence of availability of NMT monitors, timed intubation has beenpracticed. However, patient factors1 such as age, gender,7medical condition (ASA physical status), body weight affect thepharmacokinetics and pharmacodynamics of the drug.

Onreviewing the literature, we found that although, clinically acceptableconditions have been obtained with rocuronium 0.6mg/kg in 90 seconds, therehave not been many studies to quantify the proportion of patients havingexcellent conditions and time required thereof for a standard observableendpoint i.e, disappearance of either three (T1) or all twitches (T0) after aTOF stimulus. The literature does not indicate which endpoint provides the bestintubating conditions.

Thereforethere is a need to ascertain the percentage of healthy routine patientsachieving excellent intubating conditions and the time taken to achieve thesewith rocuronium 0.6mg/Kg using defined monitor i.e, TOF stimulation and associatedpost operative sore throat if any.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 to 60 yrs of either sex 2.ASA physical status I and II 3.Planned for elective surgery under general anaesthesia receiving rocuronium 0.6 mg/Kg for endotracheal intubation.

排除标准

  • 1.Patient refusal to participate in the study 2.Patients with history of neuromuscular disease 3.Patients having anticipated difficult airway 4.Patients with BMI <20 and >30 5.Patients unable to converse in Hindi or English.

结局指标

主要结局

Number of patients having excellent intubating conditions with rocuronium 0.6mg/Kg

时间窗: After endotracheal intubation

次要结局

  • a)Mean time to achieve T1 or T0(b)Intubating conditions at T1 or T0)

研究者

申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验