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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Drug Concentration | Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period. | Perioperative |
| Perioperative Complication Rate | including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death | Up to 30 days postoperative |
| Fat percentage (%) | Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system | Baseline and Postoperative Day 1 |
| Weight | Body weight will be measured in kilograms using the InBody S10 body composition analyzer | Baseline and Postoperative Day 1 |
| Waist circumference | Waist circumference will be measured in centimeters using the InBody S10 analyzer | Baseline and Postoperative Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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
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Eligible participants were adults aged 18 to 65 years with an ASA physical status of I-III and a body mass index (BMI) greater than 24 kg/m², who were scheduled to undergo surgery under general anesthesia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TINGLI, Doctor of Philosophy | Contact | 0577-88002664 | liting1021@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medical University第二附属医院和温州医科大学附属的玉英儿童医院 | Wenzhou | Zhejiang | 325802 | China |
There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Plasma Samples 血浆样本
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |