Dex vs Dazzle: Dexmedetomidine vs Midazolam for Intraoperative Sedation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Bradycardia
研究概览
简要总结
This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia.
The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.
Secondary objectives included the determination of superiority regarding the postoperative period.
For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.
详细描述
This study was a randomized, open clinical trial.
Patients undergoing surgery under regional (neuraxial or brachial plexus block) anesthesia were randomly assigned into one of two groups.
Patients in one of the groups (called MDZ) were initially sedated with a 0.05mg/Kg bolus dose of Midazolam.
The ones in the other group (called DEX) were initially sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes, followed by continuous infusion at 0.2 to 0.8 µg/Kg/h.
In order to achieve a Richmond Agitation-Sedation Scale (RASS) score between -3 and -1, the following breakthrough doses were used as necessary:
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
- None
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
- •Undergoing surgery under regional anesthesia
排除标准
- •The presence of any Bradyarrhythmia;
- •New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%;
- •Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.
研究组 & 干预措施
DEX
Patients undergoing surgical procedures under regional anesthesia sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes followed by continuous infusion at 0.2 to 0.8 µg/Kg/h, along with 0.5µg/Kg bolus breakthrough doses of Fentanyl as necessary to achieve a RASS score between -3 and -1.
干预措施: Dexmedetomidine (Drug)
MDZ
Patients undergoing surgical procedures under regional anesthesia sedated with a 0.05mg/Kg bolus dose of Midazolam, along with 0.02 mg/Kg bolus doses of Midazolam plus 0.5µg/Kg bolus doses of Fentanyl as necessary to achieve a RASS score between -3 and -1
干预措施: Midazolam (Drug)
结局指标
主要结局
Bradycardia
时间窗: Intraoperative
Heart Rate \< 50 heartbeats per minute
Hypotension
时间窗: Intraoperative
Mean Arterial Pressure \< 55mmHg
Depth of Sedation
时间窗: Intraoperative
Number of breakthrough doses necessary to achieve RASS score between -3 and -1
Respiratory depression
时间窗: Intraoperative
Use of supplemental oxygen flow greater than 2L/min or endotracheal intubation for mechanical ventilation
次要结局
- Shivering(Up to 2 hours after end of surgery)
- Delirium(2 days)
- Length of Hospital Stay(Until Discharge, up to 30 days)
- Residual Sedation(Up to 2 hours after surgery)
- Pain(2 days)
- Quality of Sleep(2 days)
研究者
João manoel Silva Junior
Director, Department of Anesthesiology
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo