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临床试验/NCT02634255
NCT02634255Unknown3 期

The Prospective Randomized Comparison of the Onset Time of Rocuronium in Patients Undergoing Emergency and Elective Surgery

Diskapi Yildirim Beyazit Education and Research Hospital0 个研究点目标入组 50 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
50
主要终点
Train of Four Ratio (TOF 0.1)

研究概览

简要总结

Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds after intravenous injection, patients can be intubated.

Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of this study is to investigate the effect of patient anxiety levels on the onset time of rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.

详细描述

After obtaining ethics committee approval, American Society of Anesthesiologists physiological status 1 (ASA 1) patients, undergoing elective inguinal hernia repair and acute appendectomy, will be included to trial.

Patients will be taken to the operating room without premedication. Spielberger's State-Trait Anxiety Inventory (STAI) will be administered to patients for determining anxiety level.

Electrocardiogram, blood pressure and peripheric oxygen saturation (SpO2) will be monitored. After opening intravenous access on hand dorsum, ringer lactate solution will be given. Neuromuscular monitoring and drug injections will be done as described in "Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents".

TOF-Guard SX acceleromyograph (Organon-Teknika) will be monitored on corrugator supercilii muscle because of its sensitivity to laryngeal muscles. In induction of anesthesia, propofol 2 mg kg-1 and fentanyl 1 mcg kg-1 will be administered intravenously. After loss of conscious, TOF-Guard SX will be calibrated and then 0.6 mg kg-1 rocuronium will be administered in 5 seconds. 20 milliampere (mA) current TOF stimulation (200 ms, square wave, 2 Hz for 1.5 s) will be repeated in every 15 s. Patients will be intubated in TOF 0.1 time.

STAI score, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, SpO2, TOF 0.1 time and intubation conditions will be compared between two groups.

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
Single (Participant)

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

  • BMI 18,5-24,9

排除标准

  • Allergy to used drugs during anesthesia
  • Neuromuscular disease
  • Liver and kidney failure
  • Heart failure
  • Anticipated difficult airway
  • Using aminoglycosides
  • BMI<18,5 and BMI>25

研究组 & 干预措施

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

干预措施: Rocuronium elective surgery (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

干预措施: Propofol (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

干预措施: Fentanyl (Drug)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

干预措施: Ringer Lactate (Other)

Rocuronium elective surgery

Active Comparator

patients undergoing inguinal herniorrhaphy

干预措施: Acceleromyography device (Device)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

干预措施: Rocuronium emergency surgery (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

干预措施: Propofol (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

干预措施: Fentanyl (Drug)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

干预措施: Ringer Lactate (Other)

Rocuronium emergency surgery

Experimental

patients undergoing appendectomy

干预措施: Acceleromyography device (Device)

结局指标

主要结局

Train of Four Ratio (TOF 0.1)

时间窗: 90 seconds after induction

anxiety score

时间窗: 15 minutes before induction

次要结局

未报告次要终点

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gamze GULGUN

Md

Diskapi Yildirim Beyazit Education and Research Hospital

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