The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Incidence of intraoperative hypotension
研究概览
简要总结
The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.
详细描述
Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve.
In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200).
However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient scheduled for surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III
排除标准
- •Patient refusal
- •Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis)
- •Contraindications or allergy to dexmedetomidine or remimazolam administration
- •Emergency surgery
- •Pregnancy
研究组 & 干预措施
Remimazolam Group
sedation with remimazolam
干预措施: Remimazolam (Drug)
Dexmedetomidine group
sedation with dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of intraoperative hypotension
时间窗: Intraoperative period
mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline
次要结局
- Intraoperative Ramsay sedation scale(Intraoperative period)
- Incidence of hypoxia(Intraoperative period)
- Incidence of intraoperative bradycardia(Intraoperative period)
- Incidence of intraoperative hypertension(Intraoperative period)
- Incidence of respiratory depression(Intraoperative period)
- Number of phenylephrine, ephedrine, atropine administered(Intraoperative period)
研究者
Gyeong-Jo Byeon, MD, PhD
Associate professor for fund
Pusan National University Yangsan Hospital