Comparison of Recovery Profile After Total Intravenous Anesthesia Between Remimazolam With Flumazenil and Propofol in Patients Undergoing Thyroidectomy: A Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 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
This prospective, randomized, single-blinded study is designed to compare the recovery profile between propofol-based total intravenous anesthesia (TIVA) and remimazolam-based TIVA in patients undergoing thyroidectomy. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery. We hypothesize that remimazolam-based TIVA antagonized by flumazenil can significantly shorten the time from the end of anesthetic administration to eye-opening compared to propofol-based TIVA.
详细描述
Adult patients undergoing elective thyroidectomy are randomly allocated to receive propofol-based TIVA (n=35) or remimazolam-based TIVA (n=35). The recovery profile including the time from the end of anesthetic administration to eye-opening, the time from the end of anesthetic administration to extubation, hemodynamic stability, stability of anesthetic depth, duration of post-anesthetic care stay, the incidence of postoperative nausea and vomiting during the first 24 hours, and the quality of recover 24 hours after surgery using the quality of recovery-15 was assessed by an investigator. The primary outcome is the time from the end of anesthetic administration to eye-opening.
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
- Single (Participant)
盲法说明
Patients will receive general anesthesia, therefore they cannot know their anesthetic agents.
Physicians involved in this study will investigate the outcomes.
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective thyroidectomy under general anesthesia
- •American Society of Anesthesiologists (ASA)physical classification I-II
- •Willingness and ability to sign an informed consent document
排除标准
- •American Society of Anesthesiologists (ASA)physical classification III or more
- •BMI > 40kg/m^2
- •Allergies to anesthetic or analgesic medications (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, sugammadex, flumazenil)
- •Patients who receive mechanical ventilation morethan 2 hours after surgery
- •Patients who receive the following medications within 24 hours prior to general anesthetics: anxiolytics, antipsychotics, rifampicin, succinycholine, neostigmine, flumazenil, cyclosporin
- •Patients with galactose intolerance or Lapp Lactase deficiency or glucose-galactose malabsorption
- •Medical or psychological disease that can affect the treatment response
研究组 & 干预措施
remimazolam group
In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil 0.2mg, is administered at the end of surgery. In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
干预措施: remimazolam-based TIVA (Drug)
propofol group
In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
干预措施: propofol-based TIVA (Drug)
结局指标
主要结局
Difference in eye opening time between the two groups
时间窗: Up to the first eye opening from stopping injection of anesthetics
difference in eye opening time after stopping injection of anesthetics (From the end of anesthetic administration to the first eye opening)
次要结局
- Difference in extubation time between the two groups(Up to extubation from stopping injection of anesthetics)
- Modified Aldrete score(Within 5 minutes of arrival at the post-anesthetic care unit)
- length of post-anesthetic care unit stay(immediately after discharge from the post-anesthetic care unit)
- Postoperative nausea and vomiting during the first 24 hours postoperatively(during the first 24 hours postoperatively)
- postoperative quality of recovery(at 24 hours postoperatively)
- Intraoperative hemodynamic stability(during the operation)
- Intraoperative anesthetic depth stability(during the operation)
研究者
Jeong-Hwa Seo
Professor
Seoul National University Hospital