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临床试验/NCT01824758
NCT01824758已完成4 期

The Effect of Esmolol on Pain Due to Rocuronium Injection Pain

Ankara Diskapi Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013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
发起方
入组人数
90
试验地点
1
主要终点
The injection pain due to rocuronium

研究概览

简要总结

90 American society of anesthesiology (ASA) physical status I and II patients undergoing general anesthesia for elective surgery will be included in the study. Patients will be randomized into three groups. Group E will receive esmolol (1 mg/kg), Group IL lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL), followed by a 0.05 mg/kg rocuronium. After intravenous induction with propofol, adequate muscle relaxation for intubation will be received by 0.5 mg/kg rocuronium.

详细描述

Patients will be observed after injection of rocuronium 0.05mg/kg, then immediately asked if they have pain in the arm. The response are assessed; discomfort, pain, and withdrawal of the hand are recorded and graded using a 4-point scale (none, mild, moderate, or severe). After the intubating dose of rocuronium, withdrawal reactions are scored as follows: (a) no pain response, (b)pain limited to the wrist, (c) pain limited to the elbow/shoulder, or (d) generalized pain response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status I and II patients
  • Undergoing general anesthesia for elective surgery

排除标准

  • Known allergy to esmolol or lidocaine
  • Chronic pain
  • Pregnancy
  • Withdrawal of consent by the patient

研究组 & 干预措施

brevibloc (esmolol)

Experimental

Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)

干预措施: Esmolol (Drug)

brevibloc (esmolol)

Experimental

Group E will receive esmolol (1 mg/kg), Group L lidocaine (0.5 mg/kg)and Group C placebo(NaCl 0.9%, 5 mL)

干预措施: rocuronium (Drug)

Aritmal (Lidocaine)

Active Comparator

Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

干预措施: Lidocaine (Drug)

Aritmal (Lidocaine)

Active Comparator

Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

干预措施: rocuronium (Drug)

Placebo (NaCl 0.9%, 5 ml)

Placebo Comparator

Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

干预措施: rocuronium (Drug)

Placebo (NaCl 0.9%, 5 ml)

Placebo Comparator

Group E: esmolol (1 mg/kg) Group L: lidocaine (0.5 mg/kg) Group C: placebo(NaCl 0.9%, 5 mL)

干预措施: Placebo (Drug)

结局指标

主要结局

The injection pain due to rocuronium

时间窗: 1 month

Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

次要结局

  • Score on pain due to injection of rocuronium(1 month)

研究者

发起方
Ankara Diskapi Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Kavak Akelma

Specialist

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

研究点 (1)

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