Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients: A Prospective Cohort Study
Overview
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).
Primary outcome measures
- Plasma Drug Concentration [Time frame: Perioperative]
- Perioperative Complication Rate [Time frame: Up to 30 days postoperative]
- Fat percentage (%) [Time frame: Baseline and Postoperative Day 1]
- Weight [Time frame: Baseline and Postoperative Day 1]
- Waist circumference [Time frame: Baseline and Postoperative Day 1]
Eligibility criteria
Inclusion criteria
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital and Yuying Children's Hospital Affiliated to Wenzhou Medica — Wenzhou
Identifiers
NCT: NCT07530848 · SAHoWMU-CR2026-03-207