Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients: A Prospective Cohort Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Second Affiliated Hospital of Wenzhou Medical University
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Plasma Drug Concentration
概览
简要总结
This observational study aims to investigate the impact of body composition on the absorption, distribution, and metabolism of anesthetic drugs, as well as on the incidence of complications in overweight and obese patients. The primary research question is whether specific body composition parameters in this population influence drug pharmacokinetics and complication rates. By integrating pharmacokinetic parameters, adverse drug reactions (ADRs), and clinical complications, the study will analyze variations in sufentanil kinetics under different body composition conditions. Under the guidance of research personnel, participants will undergo non-invasive body composition assessment using the nBody S10 analyzer. Key metrics collected will include, but are not limited to, mineral content, muscle mass, lean body mass (LBM), total body weight, and body fat percentage (BFP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Aged 18-65 years with ASA physical status I-III
- •Participants were divided into a normal control group (18.5 \< BMI \< 23.9 kg/m²) and an experimental group (BMI \> 24 kg/m²)
- •Voluntary participation with written informed consent approved by the Ethics Committee
- •No cognitive or verbal communication impairments, with the ability to fully cooperate with the study procedures
排除标准
- •1: Severe organ dysfunction, including severe hepatic or renal insufficiency, unstable coronary syndrome, uncontrolled hypertension, and other severe cardiovascular diseases
- •2: History of chronic pain or long-term use of opioids/sedatives; preoperative use of potent CYP3A inhibitors or inducers
- •3: Contraindications to body composition measurement via Bioelectrical Impedance Analysis (BIA), including abdominal wall stoma, massive ascites, limb amputation/absence, and presence of cardiac pacemakers or implantable cardioverter-defibrillators (ICDs)
- •4: Women who were pregnant or breastfeeding were excluded from the study
- •5: Known hypersensitivity or allergy to study medications
- •6: Any other condition deemed by the investigator to make the patient unsuitable for participation, including but not limited to severe psychiatric disorders or legal restrictions
研究组 & 干预措施
observation group
Patients aged 18 to 65 years, with ASA physical status I-III and a BMI > 24 kg/m², undergoing surgery under general anesthesia.
Patients aged 18 to 65 years, with ASA physical status I-III and a 18.5 kg/m² < BMI < 23.9 kg/m², un
control group
结局指标
主要结局
Plasma Drug Concentration
时间窗: Perioperative
Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.
Perioperative Complication Rate
时间窗: Up to 30 days postoperative
including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death
Fat percentage (%)
时间窗: Baseline and Postoperative Day 1
Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system
Weight
时间窗: Baseline and Postoperative Day 1
Body weight will be measured in kilograms using the InBody S10 body composition analyzer
Waist circumference
时间窗: Baseline and Postoperative Day 1
Waist circumference will be measured in centimeters using the InBody S10 analyzer
次要结局
未报告次要终点