A Randomized, Parallel, Open-label With Blinded Assessment Study Comparing Hemodynamic Profiles Between Remimazolam- and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Robot-assisted Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- MAP (Time-Weighted Average)
研究概览
简要总结
This single-center study at CHA Ilsan Medical Center compares intraoperative hemodynamics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery requiring pneumoperitoneum and steep Trendelenburg positioning.
详细描述
This study aims to compare intraoperative hemodynamic characteristics between remimazolam- and propofol-based total intravenous anesthesia (TIVA) in patients undergoing robot-assisted gynecologic surgery. Continuous invasive blood pressurewill be analyzed to evaluate time-weighted average (TWA) and area-under-the-curve (AUC) differences between groups. The study is designed as a randomized, parallel, open-label with blinded assessment trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients <65 years of age
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled to undergo robotic hysterectomy under general anesthesia
排除标准
- •Body mass index (BMI) > 35 kg/m²
- •Baseline hypotension (systolic blood pressure <100 mmHg) or bradycardia (heart rate <60 bpm)
- •History of ischemic heart disease or cardiac conduction block
- •Significant cardiopulmonary disease, including hypoxemia (SpO₂ <90%), uncontrolled asthma, or chronic obstructive pulmonary disease (COPD)
- •Use of inhalational anesthetics during anesthesia
- •Conversion from robotic/laparoscopic surgery to open laparotomy
研究组 & 干预措施
Group_P
TIVA with propofol plus remifentanil
干预措施: Propofol (Drug)
Group_R
TIVA with remimazolam plus remifentanil
干预措施: Remimazolam (Drug)
结局指标
主要结局
MAP (Time-Weighted Average)
时间窗: From induction start (first anesthetic administration) to operating room exit (transfer from OR), approximately up to 5 hours per participant.
Continuous invasive arterial pressure is recorded throughout anesthesia. For each participant, TWA-MAP is computed as the integral of MAP over elapsed time divided by total observation time (trapezoidal rule). Data are aggregated at \~1-min resolution when possible. Implausible artifacts (e.g., MAP \<30 or \>180 mmHg) are excluded. The primary comparison is the between-group difference in TWA-MAP (Remimazolam vs Propofol) for validating hypothesis(remimazolam-based TIVA maintains ≥20% higher intraoperative MAP than Propofol-based TIVA). Primary analysis will use ANCOVA adjusting for baseline MAP and prespecified covariates, with a one-sided significance level of 0.05.
次要结局
- Area Under the Curve (AUC) for Hypertensive Burden(From anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).)
- Area Under the Curve (AUC) for Hypotensive Burden(From anesthesia induction to operating room exit, assessed continuously during surgery (approximately 2 to 5 hours per participant).)
研究者
Joohyun Lee
Assistant Professor, Department of Anesthesiology and Pain Medicine, CHA University
Ilsan Cha hospital