Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plasma concentration of Propofol
研究概览
简要总结
This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.
详细描述
Remifentanil and Propofol are administered intravenously as an opioid pain reliever and hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of anesthesia or sedation to each patient, few side effects.
Entropy° is an index derived from the electroencephalographic signal of patients, validated for the evaluation of the level of narcosis during general anesthesia.
ANI ° (nociception index analgesia) is an index using the ventilatory physiological variability of the sinus rhythm validated to monitor patient's analgesia during general anesthesia.
These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure satisfactory levels of anesthesia by administering products at minimum effective doses.
The authors propose to determine whether, for a comparable target effect (analgesia and monitored sedation), plasmatic concentrations and administration rates of propofol and remifentanil necessary during general anesthesia for a comparable surgical stimulus are the same in populations of obese and non obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (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
- •Obese patients group:
- •Age ≥ 18 years old
- •Severe and morbidly obese patients (35kg / m2≤IMC <55kg / m2).
- •Patients undergoing general anesthesia for laparoscopic susmesocolic surgery (bariatric surgery or cholecystectomy).
- •Patients who have given their consent in the manner described by the public health law of August 9,
- •Patients benefiting from a Social Security scheme.
- •Group of non-obese patients:
- •Age ≥ 18 years old
- •Patients with normal weight or slightly overweight (19 <BMI <30).
- •Patients receiving general anesthesia for laparoscopic susmesocolic surgery (cholecystectomy).
- •Patients who have given their consent in the manner described by the public health law of August 9,
- •Patients benefiting from a Social Security scheme.
排除标准
- •Patient refusal
- •Age <18 years old
- •Protected adults and vulnerable persons
- •Pace maker
- •General anesthesia in the 24 hours preceding this surgery
- •Proven or suspected dysautonomia
- •Premedication by gabapentin Neurontin °
- •Locoregional peri-medullary analgesia technique used concomitantly during the pre- and intraoperative period.
- •Unbalanced dysrhythmic heart disease (AC / FA; extrasystoles; non-sinus rhythm)
- •Pregnant or breastfeeding woman
- •Intubation impossible planned
- •Hypersensitivity to the products used
- •Allergy to peanut or soy
研究组 & 干预措施
Obese patients
Severe and morbidly obese patients (35²≤BMI <55)
干预措施: Pharmacokinetic of propofol and remifentanil (Drug)
Non Obese patients
Patients with normal weight or slightly overweight (19 <BMI <30).
干预措施: Pharmacokinetic of propofol and remifentanil (Drug)
结局指标
主要结局
Plasma concentration of Propofol
时间窗: At the exsufflation of the pneumoperitoneum
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil
时间窗: At the exsufflation of the pneumoperitoneum
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
次要结局
未报告次要终点