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临床试验/NCT05574257
NCT05574257已完成不适用

Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.

Wonkwang University Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
The incidence of perioperartive hypothermia

研究概览

简要总结

After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.

详细描述

Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.

If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.

At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
  • American Society of Anesthesiologists' physical status class (ASA) award class I-III.

排除标准

  • Patients with fever before surgery
  • Patients taking antipyretics before surgery
  • Patients who are chronically using anti-inflammatory drugs
  • High-risk patients with ASA class IV or higher
  • Patient who refused sedation
  • Patients with thyroid dysfunction.

研究组 & 干预措施

Group P

Active Comparator

The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).

干预措施: Propofol (Drug)

Group R

Experimental

The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).

干预措施: Remimazolam (Drug)

结局指标

主要结局

The incidence of perioperartive hypothermia

时间窗: At PACU (Post Anesthesia Care Unit)

measure the body temperature three times on the tympanic membrane and enter the highest value.

次要结局

  • core body temperature(At PACU)
  • shivering grades(At PACU)

研究者

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

Cheol Lee,MD,PhD,

Professor of Anesthesiology and Pain Medicine

Wonkwang University Hospital

研究点 (1)

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