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临床试验/NCT01937611
NCT01937611Unknown4 期

Comparison of Dexmedetomidine and Midazolam as Intramuscular Premedication for Suspension Laryngoscopy

Guangzhou First People's Hospital1 个研究点 分布在 1 个国家目标入组 40 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
发起方
入组人数
40
试验地点
1
主要终点
Perioperative heart rate response

研究概览

简要总结

Many studies have been conducted for the feasibility of using dexmedetomidine as premedication. However, bradycardia and hypotension frequently occurred following the premedication with dexmedetomidine, either via intramuscular or intravenous route. This is particularly true when using a high dose of dexmedetomidine: a intramuscular dose over 2 μg•kg-1 or a intravenous dose over 1 μg•kg-1 can elicit marked decreases in heart rate and mean arterial blood pressure. Subsequent studies using high-dose dexmedetomidine further revealed the potential impact of its detrimental haemodynamic profile on clinical outcomes. Most studies using high-dose dexmedetomidine were predominantly adopted with the dose-finding study performed by Aho and colleague, whom reported that 2.5 μg•kg-1 dose of intramuscular dexmedetomidine was comparably sedative and anxiolytic to 0.08 mg•kg-1 midazolam. However, few investigations have addressed the clinical effects of low-dose dexmedetomidine as premedication. Considering modern anaesthesia has advanced a long way towards eliminating the routine need for a deep preoperative sedation. It has, therefore, become desirable to asses dexmedetomidine as an effective premedication using a moderate sedative dose to minimize its undesired hemodynamic effects. We set a prospective study to compare the sedative, haemodynamic, adjuvant anaesthetic effects and patient's satisfaction of low-dose dexmedetomidine (1μg•kg-1) with midazolam (0.03 mg•kg-1), the most commonly used premedication, used as an intramuscular injective administration in patients undergoing suspension laryngoscopic surgery under general anaesthesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-55 years old, American Society of Anaesthesiologists physical status I, scheduled for elective suspension laryngoscopic surgery of benign vocal fold lesions.

排除标准

  • Patients with neurological deficits
  • Pregnancy
  • Imprisonment
  • Morbid obesity (body mass index ≥ 30 kg•m-2)
  • Preoperative heart rate <45 beats•min-1
  • Second or third degree atrioventricular block
  • Antihypertensive medication with α-methyldopa, clonidine or other α2-adrenergic agonist

研究组 & 干预措施

Dexmedetomidine

Experimental

dexmedetomidine 1μg•kg-1

干预措施: Dexmedetomidine (Drug)

midazolam

Active Comparator

midazolam 0.03 mg•kg-1

干预措施: Midazolam (Drug)

结局指标

主要结局

Perioperative heart rate response

时间窗: Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.

次要结局

  • Sedation(Participants will be monitored for the duration of anesthesia and recovery, an expected average of 2 hours.)
  • Adjuvant anesthesia effect(Participants will be monitored for the duration of anesthesia, an expected average of half an hour.)
  • Patient's over-all satisfaction(On leaving the post-care unite, an expected average of 2 min.)

研究者

发起方
Guangzhou First People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiangcai Ruan

Professor, Deputy Director

Guangzhou First People's Hospital

研究点 (1)

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