Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering in Patients Undergoing Laparoscopic Gynecologic Surgery Under General Anesthesia-prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- The incidence of postanesthetic shivering (PAS)
研究概览
简要总结
The incidence of postanesthetic shivering (PAS) after general anesthesia is affected by the anesthesia maintenance agents. This study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.
详细描述
Inadvertent perioperative hypothermia and postanesthetic shivering (PAS) are common after anesthesia regardless of anesthesia methods. The incidence of perioperative hypothermia and PAS after general anesthesia has been reported to be 37.5 to 77.2% and 20 to 70%, respectively. Shivering begins when vasoconstriction, a major mechanism to prevent body heat loss, is insufficient. PAS is one of the most common discomforts in the recovery room after general anesthesia. Therefore, PAS is common in hypothermic patients.
Volatile or intravenous anesthetics impair the autonomic thermoregulatory vasoconstriction which usually preserves core body temperature. However, benzodiazepines, such as midazolam, do not significantly impair thermoregulation control, even when used in combination with common opioid doses. Remimazolam, a novel benzodiazepine, has been reported for the thermoregulatory vasoconstriction threshold and onset time of vasoconstriction in terms of core body temperature in patients undergoing robotic-assisted and laparoscopic radical prostatectomy. It decreased the vasoconstriction threshold less than propofol, one of the intravenous anesthetics, and the onset of vasoconstriction was faster than propofol.
Investigators hypothesized that remimazolam reduced the incidence of hypothermia compared to sevoflurane, one of the volatile anesthetics, and eventually lowered the frequency of PAS. Therefore, this study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients aged between 19 and 65 y, with ASA physical status classes I or II
排除标准
- •Patients with history such as thyroid disease, cardiopulmonary disease, blood coagulation disorder, liver dysfunction, cranial nerve disease, alcohol or drug abuse, a known allergy to the study drug, and those who had core body temperature > 38°C or < 36.5°C, BMI > 30 kg.m-2 or febrile illness were excluded. Patients who underwent surgery for less than 60 min, and those who did not consent to this study
研究组 & 干预措施
Group S
Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60.
For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane was administered
干预措施: Sevoflurane (Drug)
Group R
Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60.
For the maintenance of anesthesia, 1-2 mg/kg/h of remimazolam was continuously infused.
干预措施: Remimazolam (Drug)
结局指标
主要结局
The incidence of postanesthetic shivering (PAS)
时间窗: during staying in recovery room
In the recovery room, an attending anesthesiologist observed shivering. The severity of PAS was assessed with a bedside shivering assessment scale, which rated shivering as None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall, Mild (Grade 1): shivering localized to the neck and/or thorax only, Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax) and Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities
次要结局
- The severity of PAS(during staying in recovery room)
- Mean arterial pressure (MAP)(during general anesthesia)
- Heart rate (HR)(during general anesthesia)
- Core body temperature(during general anesthesia)
研究者
Cheol Lee,MD,PhD,
Professor
Wonkwang University Hospital