Randomized Controlled Trial Assessing the Effectiveness of Midazolam Premedication as an Anxiolytic, Analgesic, Sedative, and Hemodynamic Stabilizer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in noninvasive blood pressure (hemodynamic parameters 1)
研究概览
简要总结
Pre-anesthetic dosing of midazolam is commonly used in many hospitals for the induction of anesthesia, but the effect is still controversial. The purpose of this study was to evaluate the effectiveness of midazolam premedication in four aspects: anxiety reduction, pain relief, sedation and hemodynamic stability.
详细描述
Background
- Midazolam premedication is a routine practice in many hospitals, but its efficacy remains controversial. We evaluated the effectiveness of midazolam premedication with respect to anxiety and sedation levels, hemodynamic parameters, and analgesic profiles.
Methods
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Subjects
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This randomized, prospective, open-label study was approved by IRB. After written informed consent, a total of 128 female patients aged between 20 and 65 years, ASA physical status Ⅰ or Ⅱ, scheduled for elective thyroidectomy were enrolled. Exclusion criteria were: central nervous system disorders, major cardiovascular disease, chronic pain disorders, peripheral neuropathy, diabetes mellitus neuropathy, nephropathy, hepatopathy, taking any medication affecting the central nervous system or heart rate, alcohol or drug abuse, pregnancy, and contraindication to midazolam premedication. Enrolled all subjects were randomly allocated to either midazolam premedication group (Group P, n=64) or control group (Group N, n=64). Patients of group P were premedicated with intramuscular glycopyrrolate 0.2mg and midazolam 0.05 mg/kg 30 minutes before surgery, while patients assigned to Group N were only received glycopyrrolate.
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Anesthetic management
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
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status classification I or II
- •Scheduled for elective thyroidectomy under general anesthesia
排除标准
- •Central nervous system disorders
- •Major cardiovascular disease
- •Chronic pain disorders
- •Peripheral neuropathy
- •Diabetes mellitus neuropathy
- •Nephropathy
- •Hepatopathy
- •Taking any medication affecting the central nervous system or heart rate
- •Alcohol or drug abuse
- •Pregnancy
- •Contraindication to midazolam premedication
研究组 & 干预措施
Midazolam premedication group (Group P)
Patients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery.
干预措施: Propofol infusion (Drug)
Midazolam premedication group (Group P)
Patients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery.
干预措施: Midazolam premedication (Drug)
Control group (Group N)
Patients of group N were not premedicated with midazolam (Do not use placebo). [Treatment of Glycopyrrolate (0.2 mg, IM) 30 minutes prior to surgery is not intervention because it is a routine practice of this center. (-> removed from interventions)]
干预措施: Propofol infusion (Drug)
Control group (Group N)
Patients of group N were not premedicated with midazolam (Do not use placebo). [Treatment of Glycopyrrolate (0.2 mg, IM) 30 minutes prior to surgery is not intervention because it is a routine practice of this center. (-> removed from interventions)]
干预措施: Remifentanil infusion (Drug)
Midazolam premedication group (Group P)
Patients of group P were premedicated with intramuscular midazolam 0.05 mg/kg 30 minutes before surgery.
干预措施: Remifentanil infusion (Drug)
结局指标
主要结局
Change in noninvasive blood pressure (hemodynamic parameters 1)
时间窗: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring noninvasive blood pressure (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)
Change in SPI value (Analgesic profile 1)
时间窗: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring SPI (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA), which was calculated from the pulse oximetry wave
Analgesic requirement (Analgesic profile 3)
时间窗: Postoperative period (until transition to oral analgesics, up to 12 hours)
Reviewing additional medications for pain control
Change in degree of anxiety
时间窗: the anesthesiologist's visit on the day before surgery and pre-induction time after randomization
Patients completed the Beck anxiety inventory (BAI) on two separate occasions, the anesthesiologist's visit on the day before surgery and pre-induction time after randomization. The BAI was a self-report questionnaire consisting of 21 questions.
Change in sedation level
时间窗: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring the entropy value (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA).
Change in heart rate (hemodynamic parameters 2)
时间窗: At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision
Measuring heart rate (CARESCAPE Monitor B850, GE Healthcare, Milwaukee, WI, USA)
Numeric rating scale (Analgesic profile 2)
时间窗: Postoperative period (until transition to oral analgesics, up to 12 hours)
Reviewing numeric rating scale (NRS) : 0 (No pain) \~ 10 (Worst possible pain)
次要结局
- Procedure time of intubation(From the beginning of anesthesia to the completion of intubation)
- Correlation analysis between the SPI values and other parameters (heart rate, blood pressure, and entropy values)(At the time of pre-induction (initial), prior to intubation, intubation, prior to incision, and surgical incision)
研究者
Hyeon-Jeong Lee
Associate professor
Pusan National University Hospital