ObesityNCT07530848
Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients
An observational study of Obesity and Overweight, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
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
About this study
Official title: 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).
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Pharmacokinetics, Complications
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Plasma Drug Concentration
Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.
Measured: Perioperative
Perioperative Complication Rate
including atelectasis, pneumonia, respiratory failure, reintubation, acute myocardial injury, intra-abdominal infection, reoperation, and death
Measured: Up to 30 days postoperative
Fat percentage (%)
Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system
Measured: Baseline and Postoperative Day 1
Weight
Body weight will be measured in kilograms using the InBody S10 body composition analyzer
Measured: Baseline and Postoperative Day 1
Waist circumference
Waist circumference will be measured in centimeters using the InBody S10 analyzer
Measured: Baseline and Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530848
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-207
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pharmacokinetics of Anesthetic Drugs and Complications in Overweight and Obese Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07530848
- Acronym / sponsor ID
- SAHoWMU-CR2026-03-207
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Overweight, Pharmacokinetics, Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma Drug Concentration
Time frame: Perioperative
Determination of plasma sufentanil concentration by mass spectrometry during the perioperative period.
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
Fat percentage (%)
Time frame: Baseline and Postoperative Day 1
Fat percentage will be measured using the InBody S10 bioelectrical impedance analysis system
Weight
Time frame: Baseline and Postoperative Day 1
Body weight will be measured in kilograms using the InBody S10 body composition analyzer
Waist circumference
Time frame: Baseline and Postoperative Day 1
Waist circumference will be measured in centimeters using the InBody S10 analyzer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Overweight, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TINGLI, Doctor of Philosophy (0577-88002664, liting1021@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Drug Concentration (time frame: Perioperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.