Clinical trial

Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients

Opening soon · Not applicable · 1 countries · Registry ID NCT07530848

Opening soonNot applicableObservational

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

Inclusion Criteria: 1. Aged 18-65 years with ASA physical status I-III 2. Participants were divided into a normal control group (18.5 \< BMI \< 23.9 kg/m²) and an experimental group (BMI \> 24 kg/m²) 3. Voluntary participation with written informed consent approved by the Ethics Committee 4. No cognitive or verbal communication impairments, with the ability to fully cooperate with the study procedures 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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Plasma Drug ConcentrationPerioperative

Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.

Perioperative Complication RateUp to 30 days postoperative

including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death

Fat percentage (%)Baseline and Postoperative Day 1

Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system

WeightBaseline and Postoperative Day 1

Body weight will be measured in kilograms using the InBody S10 body composition analyzer

Waist circumferenceBaseline and Postoperative Day 1

Waist circumference will be measured in centimeters using the InBody S10 analyzer

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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, China