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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07530848

Enrollment

2100

Registered

2026-04-15

Start date

2026-04-10

Completion date

2028-04-30

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Obesity, Overweight, Pharmacokinetics, Complications

Brief 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

CONTACTTINGLI, Doctor of Philosophy

liting1021@aliyun.com0577-88002664

Outcome results