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临床试验/NCT02709473
NCT02709473已完成4 期

Does the Choice of Administration Sequence of Propofol and Remifentanil Affect the ED50 and ED95 of Rocuronium for Rapid Sequence Induction of Anesthesia?

Ankara University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
84
试验地点
2
主要终点
ED50 of rocuronium

研究概览

简要总结

Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.

详细描述

Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.

The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-II patients
  • patients scheduled for elective surgery

排除标准

  • suspected or known difficult airway
  • a significant renal or hepatic dysfunction
  • a known neuromuscular disease
  • hypertension
  • a known allergy to one of the drugs used in general anesthesia
  • a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
  • intake of any medication that might interact with rocuronium
  • patient refusal

研究组 & 干预措施

propofol

Active Comparator

Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration

干预措施: Propofol (Drug)

propofol

Active Comparator

Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration

干预措施: Remifentanil (Drug)

propofol

Active Comparator

Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration

干预措施: Rocuronium (Drug)

remifentanil

Active Comparator

Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration

干预措施: Propofol (Drug)

remifentanil

Active Comparator

Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration

干预措施: Remifentanil (Drug)

remifentanil

Active Comparator

Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration

干预措施: Rocuronium (Drug)

结局指标

主要结局

ED50 of rocuronium

时间窗: One minute after rocuronium injection

ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.

ED95 of rocuronium

时间窗: One minute after rocuronium injection

ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.

次要结局

  • mean arterial blood pressure(before and after 10 minutes of induction of anesthesia)

研究者

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

Menekse Ozcelik

MD

Ankara University

研究点 (2)

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