Randomized, Double-Blind, 2x2 Factorial Trial of Remimazolam vs. Midazolam on Sedation and Early Cognitive Outcomes in Patients Undergoing Traumatic or Non-Traumatic Orthopedic Surgery With Regional Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score
研究概览
简要总结
This study aims to compare two medications, Remimazolam and Midazolam, used for sedation during orthopedic surgeries performed under regional anesthesia. We want to find out which medication provides better sedation during the procedure and which one affects early recovery of brain function after surgery.
Older adults (65 years and above) undergoing surgery for bone injuries or conditions will participate. We will monitor their sedation levels, blood pressure, heart rate, side effects, and how quickly they recover after surgery. We also want to see if either medication causes fewer problems with thinking and memory shortly after surgery.
The study is designed so neither the patients nor the medical staff know which medication is being given, to ensure unbiased results. Participants will be randomly assigned to receive either Remimazolam or Midazolam.
The information gathered will help doctors choose the safest and most effective sedative for older patients undergoing orthopedic surgeries, potentially improving patient comfort and recovery.
详细描述
- Background and Rationale
- Importance of effective sedation during orthopedic surgery under regional anesthesia
- Limitations of current sedative agents (Midazolam)
- Potential advantages of Remimazolam (rapid onset/offset, safety profile)
- Gaps in knowledge about cognitive outcomes post-procedure in elderly patients
- Study Objectives
- Primary: Compare Remimazolam vs. Midazolam effects on sedation and early cognitive recovery
- Secondary: Hemodynamics, recovery time, adverse events, patient satisfaction
- Study Design
- Prospective, randomized, double-blind, 2x2 factorial
- Four arms: Remimazolam/traumatic, Remimazolam/non-traumatic, Midazolam/traumatic, Midazolam/non-traumatic
- Single-center study
- Patient Population and Inclusion/Exclusion Criteria
- Age, surgery type, cognitive baseline, health status
- Intervention Details
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study medications (Remimazolam and Midazolam) will be prepared in identical syringes by a pharmacist not involved in patient care or outcome assessment. Both participants and clinical staff (anesthesiologists, nurses, outcome assessors) will be blinded to treatment allocation. Emergency unblinding is allowed only in the event of severe adverse events.
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
- •Adults aged 65 years or older.
- •Scheduled for traumatic or non-traumatic orthopedic surgery under regional anesthesia.
- •Able to provide informed consent or have a legally authorized representative provide consent.
排除标准
- •Patient refusal to participate.
- •Mini-Cog score less than 3 (indicative of significant cognitive impairment).
- •Severe hepatic or renal failure.
- •Known allergy to benzodiazepines or propofol.
- •History of benzodiazepine dependence.
研究组 & 干预措施
Remimazolam with Traumatic Orthopedic Surgery
Participants in this arm receive intravenous Remimazolam sedation during regional anesthesia for traumatic orthopedic surgery. Sedation dosing follows the protocol of 5 mg IV over 1 minute with supplemental doses as needed. Propofol infusion may be used as an adjunct.
干预措施: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] (Drug)
Remimazolam with Non-Traumatic Orthopedic Surgery
Participants receive intravenous Remimazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and adjunct propofol use are consistent with the protocol.
干预措施: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] (Drug)
Midazolam with Traumatic Orthopedic Surgery
Participants receive intravenous Midazolam sedation during regional anesthesia for traumatic orthopedic surgery. Dosing is 0.025-0.05 mg/kg IV with supplemental doses if needed. Propofol may be used as adjunct sedation.
干预措施: Midazolam (Drug)
Midazolam with Non-Traumatic Orthopedic Surgery
Participants receive intravenous Midazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and propofol adjunct use follow the study protocol.
干预措施: Midazolam (Drug)
结局指标
主要结局
Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score
时间窗: 24 to 72 hours after surgery
Cognitive function will be evaluated using the Confusion Assessment Method (CAM) to detect delirium and acute cognitive changes between 24 and 72 hours postoperatively. This tool assesses acute confusion and cognitive impairment to determine the impact of remimazolam vs. midazolam sedation on early postoperative cognition. Unit of Measure: CAM score (binary outcome: presence or absence of delirium) Scale Information: CAM is a diagnostic algorithm (Yes/No criteria). A positive CAM indicates the presence of delirium.
次要结局
- Intraoperative blood pressure(Intraoperative period up to 72 hours post-surgery)
- Intraoperative heart rate(Intraoperative period and up to 72 h postoperative)
- Vasopressor requirement(Intraoperative period and up to 72h postoperative)
- Time to full orientation after surgery(Post-anesthesia care unit (PACU) period)
- Length of stay in PACU(Post-anesthesia care unit (PACU) period)
- Spinal Puncture Difficulty Score(During spinal puncture)
- Postoperative pain (VAS score)(0-72 hours postoperatively)
- Patient satisfaction(Up to 72 hours postoperatively)