NCT06205355招募中不适用
Comparison of Goal-directed Analgesia Using ANI (Analgesia/Nociception Index) and Standard Analgesia During General Anesthesia in Patients Undergoing Orthognathic Surgery on Postoperative Quality of Recovery: a Prospective Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Postoperative QoR-15K score
研究概览
简要总结
This study aims to determine whether goal-directed analgesia using ANI(Analgesia/Nociception Index) can improve the quality of postoperative recovery in patients undergoing maxillofacial surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adult patients 18 or older undergoing maxillary, mandibular, or bimaxillary surgery under general anesthesia.
- •adult patients who can provide written informed consent to participate in the study, understand the procedures of this study, and be able to complete patient-reported questionnaires adequately.
- •adult patients who Have made an informed decision to participate in this study and have given written consent.
排除标准
- •Patients with ASA physical status 4-5
- •Emergency surgery
- •Patients with chronic pain and related pain medications
- •Patients with hypersensitivity to general anesthesia drugs and pain medications
- •Patients with arrhythmia
- •Pregnant women
- •Others deemed unsuitable by the investigator
结局指标
主要结局
Postoperative QoR-15K score
时间窗: 24 hours after the end of surgery
Korean-translated QoR-15K (15-item Quality of Recovery (QoR-15) scale, minimum 0, maximum 150, higher scores mean a better outcome ) scores assessed by participants blinded to arm assignment 24 hours after surgery.
次要结局
- total fluid administration during surgery(during surgery)
- The time-weighted average of the segments of the total anesthesia time where the ANI value did not remain above 50 and below 70.(during surgery)
- Percentage of time with a deviation of more than ±20% from the mean blood pressure measured on the ward as a percentage of total anesthesia time(during surgery)
- estimated blood loss(during surgery)
- intraoperative opioid consumption(during surgery)
- Total postoperative non-opioid consumption(24 hours after the end of surgery)
- Patient satisfaction(24 hours after the end of surgery)
- intraoperative non-opioid consumption(during surgery)
- extubation time(from the end of surgery to endotracheal tube extubation, up to 30 minutes)
- number of participants with postoperative opioid-related side effects (constipation, pruritis, dizziness, dry mouth, somnolence)(24 hours after the end of surgery)
- postoperative pain measured by numerical rating scale (NRS) scale (minimum 0, maximum 10, higher scores mean worse outcome)(24 hours after the end of surgery)
- intraoperative use of vasoactive drugs(during surgery)
- number of participants with postoperative nausea vomiting(24 hours after the end of surgery)
- Total postoperative opioid consumption(24 hours after the end of surgery)
研究者
Eun-hee Kim
professor
Seoul National University Hospital
研究点 (2)
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