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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight

• Study Type: Observational
• Enrollment (Estimated): 2100

Contacts and Locations

• Study Contact: Name: TINGLI, Doctor of Philosophy; Phone Number: 0577-88002664; Email: liting1021@aliyun.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325802
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants were adults aged 18 to 65 years with an ASA physical status of I-III and a body mass index (BMI) greater than 24 kg/m², who were scheduled to undergo surgery under general anesthesia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
observation group; Patients aged 18 to 65 years, with ASA physical status I-III and a BMI > 24 kg/m², undergoing surgery under general anesthesia.
Patients aged 18 to 65 years, with ASA physical status I-III and a 18.5 kg/m² < BMI < 23.9 kg/m², un; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Drug Concentration	Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.	Perioperative
Perioperative Complication Rate	including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death	Up to 30 days postoperative
Fat percentage (%)	Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system	Baseline and Postoperative Day 1
Weight	Body weight will be measured in kilograms using the InBody S10 body composition analyzer	Baseline and Postoperative Day 1
Waist circumference	Waist circumference will be measured in centimeters using the InBody S10 analyzer	Baseline and Postoperative Day 1

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Pharmacokinetics; Complications
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: SAHoWMU-CR2026-03-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No