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临床试验/NCT03371953
NCT03371953Unknown4 期

Efficacy of Atracurium-vecuronium Combination in Patients Undergoing Laparoscopic Surgery:a Randomised Controlled Study

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
48
试验地点
1
主要终点
Duration-of-action of the intubating dose

研究概览

简要总结

Non-depolarising muscle relaxants are routinely employed to provide skeletal muscle relaxation during general anaesthesia (GA). Generally investigators use one or the other type of relaxant agent for this purpose and they are categorised based on their duration-of-action. Atracurium and vecuronium are two common muscle relaxant used during GA. They have an intermediate duration of action (around 40 minutes). Though they are effective relaxants and easy to reverse with reversal agents after the surgery, in case of the common laparoscopy procedures lasting an hour, they are relatively inefficient. There is evidence that when these agents are combined together (in 1:1 ratio), the duration-of-action, and reversibility improves. To render atracurium and vecuronium more efficient with laparoscopic surgery, the proposed study is aimed to evaluate the effects of combining 1/2 the respective standard doses of atracurium and vecuronium given together, in terms of its effect on the onset of block, duration-of-action, and reversibility of the neuromuscular blockade in adults undergoing laparoscopic surgery under GA. The study will be conducted with objective assessment parameter evaluation by TOF Watch SX (Organon, Teknica BV, Boxtel, The Netherlands), which will be used for facilitating institution, control, and monitoring the neuromuscular blockade during surgery. The objective of this study is to evaluate the additive effect of atracurium-vecuronium combination and profile its impact in patients undergoing laparoscopic surgery, especially in terms of increase in duration-of-action of muscle relaxation with the combination of drugs, when compared to respective individual drugs.

详细描述

The principal pharmacological effect of neuromuscular blocking drugs is to interrupt the transmission of nerve impulses at the neuromuscular junction. They are classified into depolarising (mimics the action of acetylcholine) and non-depolarising (interfere with the action of acetylcholine).In general, we use vecuronium (0.08mg/kg) or atracurium (0.5mg/kg), which are intermediate-acting non-depolarising neuromuscular blocking agents for skeletal muscle relaxation.

The main use of neuromuscular blocking drugs is to provide skeletal muscle relaxation for facilitation of intubation of the trachea and to improve surgical working conditions in the anaesthetised patients. A 2×ED95 dose of non-depolarising muscle relaxant is recommended to facilitate tracheal intubation. In practice, 90% suppression of the single twitch response is usually considered clinical evidence of adequate drug-induced skeletal muscle relaxation.

Laparoscopy has become the most preferred means of surgical access for a variety of procedures. There are many laparoscopic surgeries that last about an hour. But the duration-of-action of bolus (intubating) dose of atracurium or vecuronium when used alone is not sufficient to last for an hour. As a result, for surgeries lasting an hour(e.g. laparoscopic cholecystectomy, laparoscopic total extra-peritoneal repair, etc.), one either end up giving a top up (maintenance) dose of vecuronium/atracurium to extend muscle relaxation or withhold the add-on dose and continue with surgery towards completion. While in the former situation, the anaesthesiologist is required to wait for long even though the surgery is completed; in the latter, either the surgery gets disturbed due to patient's movement (e.g. coughing, bucking) or there may be associated hemodynamic activation, which requires deepening of anaesthesia plane; both harbinger for patient-related adversity.

There are studies which have evaluated the effect of combining two non-depolarizing neuromuscular relaxants on the profile of skeletal muscle relaxation pertinent to anaesthetic (tracheal intubation) and surgical conditions.Atracurium and vecuronium are the most common non- depolarizing muscle relaxants we routinely employ during general anaesthesia (GA). Till date, to our knowledge, there are a very few studies that have evaluated combination of atracurium and vecuronium given together.Though, the limited number of studies which analysed effects of combined neuromuscular relaxation with atracurium and vecuronium underlined that there is an additive effect, commented only on onset-of-action and reversibility of muscle relaxation effect. In addition, no study has yet evaluated the duration-of-action of atracurium- vecuronium combination in adults undergoing laparoscopic surgeries. Muscle relaxation is used for optimising laparoscopic operating conditions by preventing diaphragmatic movement due to irritation by the presence of pneumoperitoneum and achieving more intra-abdominal space for a particular intra-abdominal insufflation pressure. In this context, deeper than normally maintained level of neuromuscular blockade appears to be superior. The investigators contend that combining vecuronium and atracurium would not only facilitate increase in duration-of-action of the relaxation but also provide quality muscle relaxation for the duration of surgery.

The proposed study looks forward to analyse the effect of muscle relaxation profile of vecuronium-atracurium combination versus vecuronium-alone or atracurium-alone in patients undergoing laparoscopic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The patient, the attending anaesthesiologist, and the personnel recording the assessment parameters will be blinded to the randomisation sequence and the drug inside the 5-ml solution is supplied in a 5-ml syringe. The study drug for the three group allocation will be contained in a similar 5-ml solution (drug+0.9% saline solution).

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I and II
  • Laparoscopic surgeries likely to last for 1 hour duration

排除标准

  • Patient refusal
  • ASA physical status III and IV
  • History of hypersensitivity to atracurium or vecuronium
  • Alcoholism and drug addiction
  • Neuromuscular disorders
  • Neuropsychiatric patients
  • Hepatic and renal disease patients
  • Obese patients
  • Abnormal airway anatomy
  • Risk of oesophageal reflux

研究组 & 干预措施

Vecuronium group

Active Comparator

Vecuronium 0.08 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

干预措施: Vecuronium (Drug)

Atracurium group

Active Comparator

Atracurium 0.6 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

干预措施: Atracurium (Drug)

Vecuronium-Atracurium group

Active Comparator

Vecuronium 0.04 mg/kg + atracurium 0.3 mg/kg will be administered at induction of anaesthesia for facilitating muscle relaxation

干预措施: Vecuronium + Atracurium (Drug)

结局指标

主要结局

Duration-of-action of the intubating dose

时间窗: From the time of administration of (0-hours, baseline) till 60-minutes intraoperatively

Duration of action will be calculated from the time the drug is administered till theTOF count is 1 on the accelerometer.

次要结局

  • Reversibility of muscle relaxant effect(From the time of administration of (0-hours, baseline) till 5-minutes post administration)
  • Onset-of-action of muscle relaxation following intubating dose(From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively)
  • Qualitative intubating conditions.(From the time of administration of (0-hours, baseline) till 5-minutes intraoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amitabh Dutta

Senior Consultant & Professor

Sir Ganga Ram Hospital

研究点 (1)

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