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

NCT07530848 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Phase

Observational

Started

2026-04-10

Last updated

2026-04-15

Condition(s) studied

ObesityOverweight

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Plasma Drug Concentration — Perioperative
Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.
Perioperative Complication Rate — Up 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
Weight — Baseline and Postoperative Day 1
Body weight will be measured in kilograms using the InBody S10 body composition analyzer
Waist circumference — Baseline and Postoperative Day 1
Waist circumference will be measured in centimeters using the InBody S10 analyzer

Trial sites (1)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07530848 on ClinicalTrials.gov ↗ ← All trials in China