Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Incidence of respiratory depression
研究概览
简要总结
This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust/chin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate < 8).
详细描述
Patients will be randomized to receive either remimazolam or propofol during their first laser session, and the alternate drug during their second session 4-6 weeks later. Outcomes include respiratory depression, sedation onset and recovery times, hemodynamic changes, and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy
排除标准
- •History of previous fractional ablative laser therapy for burn scar
- •Procedure expected to last longer than 30 minutes
- •Allergy such as dextran 40 or contraindication to either of the study drugs
- •Pregnant and/or breastfeeding
- •Subjects who are unable to or choose not to give informed consent
研究组 & 干预措施
Remimazolam followed by Propofol
Patients will be randomized to receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive propofol 0.8 mg/kg IV bolus for sedation.
干预措施: Remimazolam besylate (Drug)
Remimazolam followed by Propofol
Patients will be randomized to receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive propofol 0.8 mg/kg IV bolus for sedation.
干预措施: Propofol (Drug)
Propofol followed by Remimazolam
Patients will be randomized to receive Propofol 0.8 mg/kg IV bolus for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation.
干预措施: Remimazolam besylate (Drug)
Propofol followed by Remimazolam
Patients will be randomized to receive Propofol 0.8 mg/kg IV bolus for sedation during their first laser therapy session, then 4-6 weeks later at their next laser therapy session they will receive Remimazolam 0.075 mg/kg (maximum of 5 mg) for sedation.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of respiratory depression
时间窗: up to 24 hours after procedure ends
The incidence of respiratory depression will include need for advanced airway maneuvers, or hypopnea events. Advanced airway maneuvers during the laser therapy procedure may include jaw thrust, chin lift, insertion of oral or nasal airway, or bag mask ventilation. A hypopnea event is defined as a respiratory rate \<8.
次要结局
- Time from initiation of sedation to peak sedation(up to 24 hours after procedure ends)
- Time of cessation of sedation to full recovery(up to 24 hours after procedure ends)
- Cessation of sedation to full recovery(up to 24 hours after the procedure ends)
- Satisfaction with Anesthesia(up to 24 hours after the procedure ends)
- Felling pain on injection of sedation medication(up to 24 hours after the procedure ends)
研究者
Rishi Patel
Assistant Professor-Faculty
Medical University of South Carolina