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NCT Number: NCT07530848

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Plasma Drug Concentration

    Time frame: Perioperative

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

  2. Perioperative Complication Rate

    Time frame: Up to 30 days postoperative

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

  3. Fat percentage (%)

    Time frame: Baseline and Postoperative Day 1

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

  4. Weight

    Time frame: Baseline and Postoperative Day 1

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

  5. Waist circumference

    Time frame: Baseline and Postoperative Day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

TINGLI, Doctor of Philosophy

CONTACT

[email protected]

0577-88002664

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients: A Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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