Comparison Between Remimazolam Versus Propopol Based Total Intravenous Anesthesia for Breast Surgery : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Hypotension incidence
研究概览
简要总结
Comparison of the incidence of hypotension under remimazolam and propofol-based anesthesia in patients undergoing breast surgery under general anesthesia
详细描述
The purpose of this study was to investigate whether remimazolam-based general anesthesia could reduce the incidence of hypotension in patients undergoing breast surgery under general anesthesia compared to propofol-based general anesthesia. The purpose of this study is to establish and test the hypothesis that the incidence of hypotension under general anesthesia based on remimazolam will be less than that of propofol based general anesthesia. In addition, this study compares the proportion of patients who require a vasopressor, the time taken for anesthesia induction, the time to recover from anesthesia, postoperative pain, the incidence of postoperative nausea and vomiting, the quality of postoperative recovery, and patient satisfaction.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over the age of 19 undergoing elective breast cancer surgery under general anesthesia at Seoul National University Hospital
排除标准
- •patients with acute narrow-angle glaucoma/ shock or coma/ acute alcohol poisoning/ sleep apnea/ alcohol or drug dependency/ severe or acute respiratory failure/ galactose intolerance/ Lapp lactase deficiency/ glucose galactose malabsorption/ severe hypersensitivity to dextran.
- •Patients with myasthenia gravis/ pulmonary heart disease/ chronic obstructive pulmonary disease/ bronchial asthma
- •Patients with cardiovascular diseases such as ischemic heart disease/ coronary artery disease/ angina pectoris/ myocardial infarction/ atherosclerosis/ arrhythmia/ cerebrovascular disease/ and stroke
- •Patients with chronic renal failure
- •Patients with severe hepatic impairment (Child Pugh class C)
- •Patients with American Society of Anesthesiology score III or higher
- •Patients with hypersensitivity to propofol and soy or peanuts
- •Epilepsy patients
- •Patient with fat metabolism abnormality
- •Patients with high intracranial pressure
- •Pregnant woman
- •Patients unable to use supraglottic airway due to poor dental condition
- •In cases that the researcher judges to be unsuitable for this clinical trial
研究组 & 干预措施
Remimazolam based total intravenous anesthesia
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of remimazolam and remifentanil.
干预措施: Remimazolam (Drug)
Propofol based total intravenous anesthesia
For induction and maintenance of anesthesia, total intravenous anesthesia is performed using continuous intravenous infusion of propofol and remifentanil.
干预措施: Propofol (Drug)
结局指标
主要结局
Hypotension incidence
时间窗: from induction of anesthesia to end of surgery
Incidence of hypotension (MAP \<65 mmHg) from induction of anesthesia to end of surgery
次要结局
- Use of vasopressor(from induction of anesthesia to end of surgery)
- Number of occurrences of hypotension during surgery(from induction of anesthesia to end of surgery)
- Type of vasopressor used(from induction of anesthesia to end of surgery)
- Total dose of vasopressor used(from induction of anesthesia to end of surgery)
- Blood pressure(from induction of anesthesia to end of surgery)
- Heart rate(from induction of anesthesia to end of surgery)
- Saturation of percutaneous oxygen (SpO2)(from induction of anesthesia to end of surgery)
- Patient State Index (PSi)(from induction of anesthesia to end of surgery)
- Incidence of bradycardia(from induction of anesthesia to end of surgery)
- Severity of injection pain(At the start of induction of general anesthesia)
- Incidence of intraoperative awareness(from induction of anesthesia to end of surgery)
- Incidence of intraoperative body movement(from induction of anesthesia to end of surgery)
- Incidence of use of rescue sedative agents(from induction of anesthesia to end of surgery)
- T ime from start of administration of sedative drug to loss of consciousness(from induction of anesthesia to loss of consciousness)
- Time from the end of administration of sedative to eye opening(from end of administration of sedative to eye opening)
- Time from the end of administration of sedative to response to verbal command(from end of administration of sedative to response to verbal command)
- Time from the end of administration of sedative to supraglottic airway removal(from end of administration of sedative to supraglottic airway removal)
- Numeric rating scale score in the recovery room immediately after surgery(Immediate after end of surgery)
- Subjective sleep quality on the day of surgery(During the day of surgery)
- Duration of post anesthesia care unit stay(From entering post anesthesia care unit until leaving, post-operatively 1 hour average)
- Total analgesic consumption for 24 hours after surgery(For 24 hours after the end of surgery)
- Incidence of nausea and vomiting within 24 hours after surgery(within 24 hours after surgery)
- Severity of nausea and vomiting within 24 hours after surgery(within 24 hours after surgery)
- Patient satisfaction with anesthesia(The day of operation)
- 15 item Quality of Recovery(24 hours after surgery)
- Hospital length of stay(From administration to discharge, average 4 days)
研究者
Seokha Yoo
Clinical Assistant Professor
Seoul National University Hospital