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Fentanyl in patients with high BMI or low body weight

Prediction of plasma/effect-site concentrations of fentanyl in patients with high BMI or low body weight

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1021230025
Enrollment
50
Registered
2023-09-27
Start date
2024-01-14
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Patients with high BMI (BMI >25 kg/m2) or weight loss (>20% below ideal body weight or BMI<18.5)

Interventions

None listed

Sponsors

Obara Shinju
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (Study A) 15 patients with high BMI (BMI more than 25) and 15 patients with weight loss (more than 20 per cents below ideal body weight or BMI less than 18.5) undergoing scheduled surgery under general anesthesia using fentanyl (30 patients in total) (Study B) 10 patients with high BMI (BMI more than 25) and 10 patients with weight loss (more than 20 per cents below ideal body weight or BMI less than 18.5) undergoing scheduled surgery under general anesthesia using fentanyl (20 patients in total) Ideal body weight = 22 x height (m2).

Exclusion criteria

Exclusion criteria: 1. Patients who have received fentanyl prior to surgery 2. Patients with allergy to fentanyl 3. Patients with severe hepatic or renal dysfunction or severe hypoalbuminemia 4. Patients undergoing treatment for psychiatric or neurological disorders 5. Patients with severe anemia 6. Patients whose fentanyl dose is not 3 mcg in Study A

Design outcomes

Primary

MeasureTime frame
Parameters of the model for predicting fentanyl concentrations. MDPE MDAPE

Secondary

MeasureTime frame
Compare the predictive performance of the models obtained in Study A and in previous studies (Shafer's model, Sibutani's model, Bae's model, and Bienert's model). MDPE and MDAPE The relashionships between above indices and cardiac index

Contacts

Public ContactShinju Obara

Surgical Operation Department, Fukushima Medical University Hospital

shinjn@fmu.ac.jp+81-24-547-1342

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026