Usefulness of Pupillary Reflex on Remifentanil and Morphine Consumption During Laparoscopic Surgery. A Bicentric, Prospective, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Peroperative Remifentanil consumption
研究概览
简要总结
The purpose of this study is to determine whether analgesia guided by pupillary reflex during laparoscopic surgery is effective in opioid sparing (intraoperative remifentanil and postoperative morphine).This is a prospective, randomized, controlled study performed in two centers.
详细描述
For now, intraoperative analgesia remains hard to assess in the absence of reliable and validated analgesia monitor. The analysis of pupillary reflex is a new tool to assess analgesia during the intraoperative and postoperative period.
During laparoscopic surgery, carbon dioxide insufflation that produce pneumoperitoneum may induce hemodynamics events such as tachycardia or hypertension. These events may be misleading or confusing. Actually, these events are mainly considered as insufficient analgesia. Thus, anesthesiologists deepen analgesia and/or anesthesia by increasing concentration of anesthetics or opioids. These inappropriate actions may induce hypotension and/or bradycardia especially in elderly patients. On the contrary, insufficient analgesia may exist in hypovolemic patients or in patients with neuromuscular blocking agents.
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
- None
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
- •American Society of Anesthesiologists status 1 to 4
- •Scheduled laparoscopic surgery
- •Standardized anesthesia (TCI)
- •Social security affiliation
排除标准
- •Age < 18 yrs old
- •Emergency
- •BMI ≥ 35 kg.m-2
- •Refusal of consent
- •History of ocular pathology
- •Intake of: metoclopramide, droperidol, opioids or substitutive therapies
- •Patient with chronic pain
- •Neurologic impairments
- •Neuropathic pain
- •Drug or alcohol abuse
研究组 & 干预措施
Pupillometry guided analgesia (PP)
Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
干预措施: Pupillometry guided analgesia (PP) (Device)
Pupillometry guided analgesia (PP)
Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
干预措施: Tailored remifentanil controlled infusion (Drug)
Pupillometry guided analgesia (PP)
Analgesia is guided by pupillary reflex. The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed. Administration of antihypertensive drugs or vasopressors is also guided.
干预措施: Tailored antihypertensive drug administration (Drug)
结局指标
主要结局
Peroperative Remifentanil consumption
时间窗: From the start of anesthesia to the end of surgery (<10 hours)
次要结局
- Time from extubation between the end of surgery and PACU admission(In the immediate postoperative period (<4 hours))
- Length of stay in PACU(From PACU admission to an ALDRETE score of 10 (< 4 hours))
- Immediate postoperative morphine consumption(During postanesthetic care unit (PACU) stay (<4 hours))
- Pain scores(In the immediate postoperative period (<4 hours))
- Incidence of postoperative nausea and vomiting (PONV)(In the immediate postoperative period (<4 hours))
- Number of hemodynamic events (hypertension, hypotension, tachycardia or bradycardia...)(From the start of anesthesia to the end of surgery (<10 hours))
- Use of antihypertensive agents or vasopressors(From the start of anesthesia to the end of surgery (<10 hours))
- Volume of fluid replacement(From the start of anesthesia to the end of surgery (<10 hours))