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临床试验/NCT05067829
NCT05067829Unknown不适用

Comparison of the Effect of Rocuronium Dosing Based on Ideal, Corrected or Total Body Weight on Rapid Sequence Intubation With Priming on Neuromuscular Blockage and Intubation Condition in Elderly Patients.

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
The percent of excellent intubation condition

研究概览

简要总结

With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. The use of rocuronium at a dose of 1 mg/kg in RSI also causes prolongation of the recovery of neuromuscular block. This study aimed to compare the intubation conditions and train-of-four count(TOFC) 1-2 times of the rocuronium doses with priming according to ideal body weight(IBW), corrected body weight(CBW), and total body weight(TBW) in RSI of patients aged >65 years.

详细描述

The number of elderly patients (>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. Changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. One of the reasons for rapid sequence intubation(RSI) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. Guidelines regarding this subject recommend securing the airway quickly with RSI, and it is reported that aerosol production would decrease with this method. This study aimed to compare the intubation conditions and the train-of-four count (TOFC) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(IBW), corrected body weight(CBW), and total body weight (TBW) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.

研究设计

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

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective abdominal surgery
  • Age > 65 years
  • ASA I-II -III

排除标准

  • Patient with history of allergy to rocuronium
  • Body Mass Index > 35 kg/m2
  • Patient who had history of difficult intubation or high possibility of difficult intubation
  • Neuromuscular disease
  • Kidney failure (GFR < 30 ml/dk/m2)

结局指标

主要结局

The percent of excellent intubation condition

时间窗: During intubation from start to finish of the study

Score 1: Poor jaw relaxation/ Active resistance to blade/closing vokal kord/ Severe coughing or bucking/ Vigorous limb movement Score 2: Acceptable jaw relaxation/ Intermediate vokal cord moving/ slight limb and diaphram movement score 3: relaxed laryngoscopy/ abducted vocal cords/ no limb and diphragm movement

Time to TOFC equal to 1

时间窗: During intubation from start to finish of the study

Time from rocuronium induction to TOFc equal to 1

TOF value during intubation procedure

时间窗: During intubation from start to finish of the study

Train of four monitoring during induction and intubation

Time to TOFR equal to zero

时间窗: During intubation from start to finish of the study

Time from rocuronium induction to TOFR equal to zero

次要结局

未报告次要终点

研究者

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

aysun postaci

Associate Prof. Dr

Ankara City Hospital Bilkent

研究点 (2)

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