Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil Compared to Propofol-based Total Intravenous Anesthesia in Patients Undergoing Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to eye opening (minute)
研究概览
简要总结
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery.
详细描述
Adult patients undergoing breast cancer surgery are randomized to receive either remimazolam with flumazenil or propofol-based total intravenous anesthesia. When the surgery is ended, anesthetic agents are discontinued. The study's primary outcome is a comparison of the time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents between the groups. Secondary outcomes include the time from anesthetics off to extubation/discharge from operating room (OR), BIS score at eye-opening/extubation/discharge from OR, the incidence of emergence agitation at OR, the PAT score, the modified Aldrete score, modified OAA/S (Observers Assessment of Alertness/Sedation Scale) after PACU administration. In addition, the investigators investigate postoperative pain score at 10/20/30 minutes and postoperative nausea and vomiting after PACU administration, Korean version of quality of recovery-15 in postoperative 24 hours, postoperative pain score and postoperative nausea and vomiting, postoperative opioid consumption in postoperative 24 hours.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient, age >19, scheduled for breast cancer surgery under general anesthesia
排除标准
- •Patients who are not alert before procedure
- •Day surgery
- •Hemodynamicaly unstable patients before procedure
- •Patients with history of neromuscular disease or drug use affecting neuromuscular function.
- •Patients with history of adverse reaction of allergic reaction to study drugs
- •Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
- •Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
- •Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Alcohol or drug dependence
- •Organic brain disorder
- •Patients with hypersensitive to beans or peanut
- •Patients who refuse to participate
研究组 & 干预措施
Remimazolam with flumazenil
Patients allocated to remimazolam with flumazenil group receive remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] (Drug)
Remimazolam with flumazenil
Patients allocated to remimazolam with flumazenil group receive remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: Flumazenil (Drug)
Propofol-based total intravenous anesthesia
Patients allocated to the propofol-based total intravenous anesthesia group receive propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: Propofol (Drug)
结局指标
主要结局
Time to eye opening (minute)
时间窗: 20 minutes after anesthesia emergence
The time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents
次要结局
- Incidence of emergence agitation at operating room (n(%))(Time Frame: 20 minutes after anesthesia emergence)
- The modified Observers Assessment of Alertness/Sedation Scale (Score)(30 minutes after post anaestheisa care unit adminstration)
- Postoperative Pain (score)(upto 24 hours)
- Postoperative opioid consumption (The number of analgesic use)(upto 24 hours)
- Bispectral index score (Score)(During 20 minutes after anesthesia emergence (3 point : Time from anesthetics off to eye opening/extubation/discharge from operating room))
- The modified Aldrete score (Score)(30 minutes after post anaestheisa care unit adminstration)
- Time to emergence (minutes)(20 minutes after anesthesia emergence)
- Postoperative nausea and vomiting (The incidence of PONV, n(%))(from post anaestheisa care unit administation to post anaestheisa care unit discharge (during 30-40 minutes, upto 1 hours))
- Postoperative quality of recovery (score)(upto 24 hours)
研究者
Yunseok Jeon
Professor
Seoul National University Hospital