Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam in Elderly Patients Undergoing Hip Joint Surgery: a Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Difference in eye opening time between the two groups
研究概览
简要总结
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.
详细描述
Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.
Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.
However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.
Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.
Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 65 years old scheduled for hip joint surgery
排除标准
- •Patients with impaired consciousness or delirium before surgery
- •Patients who are hemodynamically unstable before surgery
- •Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
- •Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
- •Patients with known allergy to benzodiazepine, flumazenil
- •Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Patients with hypersensitivity to Dextran40
- •Patients who have been taking benzodiazepine for long term
- •Patients with end stage renal disease requiring hemodialysis
- •Patients with history of acute angle glaucoma
- •Patients with alcohol or substance dependence
- •ASA classification 4 or 5
研究组 & 干预措施
Normal saline group
Participants are administered 3mL of 0.9% normal saline at the end of anesthesia
干预措施: normal saline (Drug)
Flumazenil group
Participants are administered 0.3mg(3mL) of flumazenil at the end of anesthesia
干预措施: Flumazenil (Drug)
结局指标
主要结局
Difference in eye opening time between the two groups
时间窗: Up to two hours
Time, after stopping injection of remimazolam, to eye opening
Difference in extubation time between the two groups
时间窗: Up to two hours
Time, after stopping injection of remimazolam, to extubation
次要结局
- Actual dose of flumazenil(Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit)
- Side effects of flumazenil usage(Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit)
- Occurrence of re-sedation(Up to two hours, From end of anesthesia to discharge form the post-anestheic care unit)
研究者
SANGWOOK SHIN
Professor
Pusan National University Yangsan Hospital