L'Effet du rémifentanil Sur la sensibilité à la Douleur mesurée Objectivement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
It is a clinical study investigating the relationship between objectively measured pain threshold and the need for escalating doses of remifentanyl opioids. This study is expected to include approximately 40 participants.
The aim of the study is to objectively measure the analgesic effect of an increasing dose of opioids just before anesthesia.
详细描述
This is a prospective interventional study. Participants will undergo controlled pressure stimulation using an Algometer device to determine their pressure pain threshold (PPT).
Pressure pain threshold will be assessed at baseline (0 ng/mL) and during stepwise increasing target-controlled intravenous remifentanil concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.
Investigators hypothesize that increasing plasma concentrations of remifentanil will be associated with a corresponding increase in pressure pain threshold.
In addition, postoperative analgesic consumption will be recorded following surgery. This will allow the investigators to explore a potential association between intraoperative pressure pain threshold modulation and postoperative pain outcomes or analgesic requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients who are able to volunteer
- •ASA 1, 2and 3
排除标准
- •Refusal to participate;
- •Body mass index (BMI) > 30 kg/m²;
- •Allergy to any medication used for anesthesia;
- •Chronic pain or regular use of analgesics;
- •Severe ventricular dysfunction, pulmonary hypertension, or uncontrolled arrhythmia;
- •Non-elective surgery;
- •Participation in another study within the last 3 months;
- •Pregnancy or breastfeeding;
- •Severe renal or hepatic impairment
研究组 & 干预措施
Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption
This is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored.
Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.
Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented.
干预措施: Pressure pain theshold measured under remifentanil (ultiva®) infusion (Device)
Pressure pain theshold measured under remifentanil (Ultiva®) infusion and analgesic consumption
This is a single-arm study in which all patients will follow the same protocol. Study participation begins on the day of surgery, immediately prior to anesthesia induction, when the primary measurements are performed, and ends 24 hours postoperatively. During this period, analgesic consumption and adverse events will be monitored.
Intervention 1: Pressure pain threshold under remifentanil infusion. Pressure pain threshold will be assessed using an algometer at baseline (0 ng/mL) and during stepwise increases in target-controlled intravenous remifentanil (Ultiva®) concentrations of 1, 2, and 3 ng/mL. Measurements will be obtained at each concentration level after achieving steady-state conditions.
Intervention 2: Postoperative analgesic consumption and adverse events. Perioperative and postoperative analgesic drug consumption will be recorded. All adverse events will be systematically monitored and documented.
干预措施: Postoperative PCA IV morphine (Sterop®) consumption and adverse events history (Drug)
研究者
Arnaud Bollens
Principal investigator
Université Libre de Bruxelles