A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain: NRS
研究概览
简要总结
Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are many descriptive studies supporting the correlation of ANI score and pain score but there are still very few randomized control studies which report the efficacy of ANI in clinical practice.
详细描述
Objective
To evaluate the efficacy of ANI to guide the administration of intraoperative fentanyl.
Methods: Sixty female patients undergoing breast surgery with balanced anesthesia will be randomized into 2 groups. The first group will receive fentanyl according to standard practice of attending anesthesiologists. The second group will receive fentanyl according to ANI score protocol.
Primary outcome: Postoperative pain numeric rating scale (NRS) score during 60 minutes in postanesthetic care unit (PACU).
Secondary outcomes: Total intraoperative dose of fentanyl and postoperative nausea/vomiting and sedation score in PACU.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults female undergoing elective breast surgery
- •American Society of Anesthesiologists (ASA) classification I-III
- •Body mass index (BMI) 18.5-35 kg/m2
排除标准
- •Implanted pacemaker
- •Cardiac arrythmia
- •Autonomic nervous system (ANS) disorder, e.g. epilepsy, stroke
- •Chronic opioid use
- •Chronic pain
- •On beta-blocker, calcium channel blocker, or other drugs to control arrythmia
- •Previous mastectomy
- •Pregnancy
- •On Nsaids
研究组 & 干预措施
Control group
Intraoperative fentanyl administration will be guided by standard protocol
干预措施: Standard protocol (Procedure)
ANI group
Intraoperative fentanyl administration will be guided by ANI protocol
干预措施: ANI protocol (Procedure)
结局指标
主要结局
Postoperative pain: NRS
时间窗: during 60 minutes in PACU
Measure pain numeric rating scale (NRS) every 15 minutes. NRS has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain.
次要结局
- Intraoperative fentanyl consumption(During intraoperative period)
- Intraoperative ANI score(During intraoperative period)
- Postoperative nausea/vomiting(During 24 hours postoperatively)
- Postoperative sedation score(During 24 hours postoperatively)
研究者
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University