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

NCT07530848 | Not Yet Recruiting

• 1 other identifier: SAHoWMU-CR2026-03-207
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Overweight

Keywords

Obesity; Overweight; Pharmacokinetics; Complications

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• : Severe organ dysfunction, including severe hepatic or renal insufficiency, unstable coronary syndrome, uncontrolled hypertension, and other severe cardiovascular diseases
• : History of chronic pain or long-term use of opioids/sedatives; preoperative use of potent CYP3A inhibitors or inducers
• : 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)
• : Women who were pregnant or breastfeeding were excluded from the study
• : Known hypersensitivity or allergy to study medications
• : 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Samples 血浆样本

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Central Study Contacts

TINGLI, Doctor of Philosophy

CONTACT

0577-88002664; liting1021@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 15, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)