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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

1: Severe organ dysfunction, including severe hepatic or renal insufficiency, unstable coronary syndrome, uncontrolled hypertension, and other severe cardiovascular diseases

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,100 Participants
are grouped into 2 trial groups
Group A: observation group
Group B: Patients aged 18 to 65 years, with ASA physical status I-III and a 18.5 kg/m² < BMI < 23.9 kg/m², un

Trial outcomes

Primary outcomes

1

Plasma Drug Concentration

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

Time frame
Perioperative
2

Perioperative Complication Rate

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

Time frame
Up to 30 days postoperative
3

Fat percentage (%)

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

Time frame
Baseline and Postoperative Day 1
4

Weight

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

Time frame
Baseline and Postoperative Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: