Can Preanesthetic Analgesia/Nociception Index (ANI) Predict Propofol Injection Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
研究概览
简要总结
Recently, Analgesia Nociception Index (ANI) has been evaluated for objectively measuring peri-operative pain and to guide intra-operative opioid administration during various surgeries.
Propofol injection pain (PIP) is a common problem and can be very distressing to the patient.
详细描述
This study aimed to the association of preanesthetic ANI scores and PIP in patients who scheduled for general anesthesia.
Before propofol administration in remifentanil group, preanesthetic ANI values (instant and mean) were checked after remifentanil to a target Ce of 4 ng/ml.
Control group received the same volume of saline as remifentanil group. Heart rate and bispectral index were checked as ANI. Point biserial correlation and ROC curve were analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
All study drugs were administered using a Minto pharmacokinetic model in a TCI device (Orchestra, Fresenius-Vial, France). The infusion pump was covered to blind the patients, investigator, and outcomes assessor
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients who scheduled for general anesthesia
- •Cognitive patients who could understand this study
排除标准
- •Patients receiving β-receptor blockers, ketamine, clonidine, or any vasoactive substance (i.e. metaraminol, ephedrine) and patients receiving neostigmine, atropine or glycopyrrolate.
研究组 & 干预措施
Control group
To maintain blinding, in the control group, the remifentanil infusion was replaced with 50 ml of normal saline in 50 ml syringe. The remifentanil (or saline) infusion was run until the pump indicated the target Ce had been achieved. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia in all patients was induced using 2 mg/kg of 2% propofol. The attending anesthesiologist asked the patients how they felt pain to evaluate pain severity of PIP while half -dose of propofol was administered. After the rest of the propofol was administered, the attending anesthesiologists asked the same question.
干预措施: Analgesia/Nociception Index (ANI) (Device)
Remifentanil group
Remifentanil 1 mg was diluted into 50 ml of normal saline. A commercial TCI pump (Orchestra Base Primea, Fresenius Vial, France) was used for the effect-site TCI of remifentanil. The study groups received remifentanil to a target Ce of 4 ng/ ml. Pharmacokinetic model for remifentanil was the Minto model (Height, Weight, and Age) Anesthesia induction and the evaluation of pain were same as control group
干预措施: Analgesia/Nociception Index (ANI) (Device)
结局指标
主要结局
The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)
时间窗: Immediately before administration of propofol (2mg/kg)
The correlation of preanesthetic ANI scores and incidence of PIP.
次要结局
- Incidence and severity of PIP(during anesthesia induction ( half-dose (1mg/kg) and full-dose of (2mg/kg) propofol administration))
- The correlation of Analgesia/nociception Index (ANI) and Propofol injection pain (PIP)(Immediately before administration of propofol (2mg/kg))
研究者
Cheol Lee,MD,PhD,
Professor
Wonkwang University Hospital