Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)
研究概览
简要总结
This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.
详细描述
This is a prospective, observational, cohort study. The exposure is the benzodiazepine sedative actually used at induction; patients are grouped as the remimazolam (RM) or midazolam (MZ) cohort based on the clinical record. Induction and maintenance are individualized by the attending anesthesiologist ; investigators only observe and collect data without altering routine care. All patients receive standard monitoring (ECG, SpO₂, non-invasive/invasive blood pressure, end-tidal CO₂, anesthetic depth). Collected data include demographics, medical history and risk factors, medication history, examination and laboratory results, and intraoperative variables (ASA class, surgery type and duration, hypotension, anesthetic and opioid doses, fluid balance, blood loss, transfusion).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 65 years or older.
- •Scheduled for elective non-cardiac surgery under general anesthesia.
- •American Society of Anesthesiologists physical status I to IV.
- •Planned airway management with tracheal intubation or a laryngeal mask airway.
- •Written informed consent provided by the participant or the participant's legally authorized representative.
排除标准
- •Long-term preoperative benzodiazepine use.
- •Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.
- •History of drug abuse or alcoholism within the past 2 years.
- •No preoperative cognitive assessment available.
- •Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than
- •7.Refusal to provide informed consent.
研究组 & 干预措施
Cohort 1: Remimazolam group (RM)
Elderly patients who receive remimazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist).
Cohort 2: Midazolam group (MZ)
Elderly patients who receive midazolam as the benzodiazepine sedative during general anesthesia induction (final dose and sequence determined individually by the attending anesthesiologist).
结局指标
主要结局
Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)
时间窗: From anesthetic induction through the end of surgery (intraoperative period)
Intraoperative hypotension burden was quantified from mean arterial pressure (MAP) recordings obtained from anesthetic induction through the end of surgery (induction and maintenance periods).
次要结局
- Time to Extubation(During anesthesia emergence)
- Vasoactive drug requirement(Induction period and entire perioperative period Cumulative dose and frequency of vasoactive agents)
- Quality of Recovery at 24 Hours Postoperatively as Assessed by the Quality of Recovery-15 (QoR-15) Questionnaire(24 hours after surgery)
- Perioperative Anxiety Assessed by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Day of surgery and postoperative day 2)
- Composite of Major Organ Complications (Postoperative Delirium, Acute Kidney Injury, Stroke, Acute Myocardial Infarction, Pulmonary Infection, In-Hospital All-Cause Mortality, Postoperative Length of Stay, and Unplanned Reoperation)(From the end of surgery until hospital discharge, an average of 7 days)
- Incidence of Anesthesia-Related Adverse Events (Composite)(perioperative)
- Length of Stay in the Post-Anesthesia Care Unit (PACU)(From PACU admission until PACU discharge readiness, assessed up to 24 hours after surgery)