Comparison of Quality of Recovery (QoR)-15 Scores According to the Use of Anesthetics During Total Intravenous Anesthesia in Female Patients Undergoing Thyroid Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
研究概览
简要总结
Remimazolam is a ultra-short-acting benzodiazepine that is rapidly metabolized in the body by tissue esterase and not accumulates in the body for long periods of infusion. In addition, similar to other benzodiazepines, it is possible to reverse the sedation and anesthetic effects through flumazenil. It has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA using remimazolam. The purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between propofol-based and remimazolam-based total intravenous anesthesia in female patients undergoing thyroidectomy. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20≤Age≤65 female Open thyroidectomy ASA-PS I-III
排除标准
- •Allergic history of any study drug
- •Taking any sedative, opioid, or sleep aid drugs
- •Psychiatric or neurological disorder
- •BMI>30 kg/m2
- •Pregnancy
- •Vulnerable patients
研究组 & 干预措施
Propofol group
Propofol based total intravenous anesthesia
干预措施: Arm I (Propofol group) (Drug)
Remimazolam group
Remimazolam based total intravenous anesthesia
干预措施: Arm II (Remimazolam group) (Drug)
结局指标
主要结局
postoperative day 1(POD1) Quality of Recovery(QoR)-15 questionnaire score
时间窗: Postoperative day 1
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value : 0, maximum value : 150, the higher the score, the better the result)
次要结局
- Tracheal extubation time(perioperative - until 48hours)
- postoperative day 2(POD2) Quality of Recovery(QoR)-15 questionnaire score(Postoperative day 2)
- Response time(perioperative - until 48hours)
- Time to recovery of self respiration(perioperative - until 48hours)
- PACU(post-anesthesia care unit) stay time(perioperative - until 48hours)
- Postoperative pain score(at admission to PACU, discharge from PACU, postoperative 6hours)
- Postoperative nausea and vomiting(at admission to PACU, discharge from PACU, postoperative 6hours)
- Postoperative sedation score(at admission to PACU, discharge from PACU)
- the incidence of administration of postoperative rescue drug(perioperative - until 72hours)
- hospital stay(preoperative - until discharge (usually 48 hours to 72hours))
- postoperative complications(preoperative - until discharge (usually 48 hours to 72hours))
研究者
Young Song
Associate professor
Gangnam Severance Hospital