Fentanyl in patients with high BMI or emaciation

JRCT ID: jRCT1021230025

Registered date:27/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with high BMI (BMI >30 kg/m2) or weight loss (>20% below ideal body weight)
• Date of first enrollment: 14/01/2024
• Target sample size: 60
• Study type: Observational

Outcome(s)

Primary Outcome

Parameters of the model for predicting fentanyl concentrations.
MDPE
MDAPE

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(Study A)
20 patients with high BMI (BMI more than 30) and 20 patients with weight loss (more than 20 per cents below ideal body weight) undergoing scheduled surgery under general anesthesia using fentanyl (40 patients in total)
(Study B)
10 patients with high BMI (BMI more than 30 kg m2) and 10 patients with weight loss (more than 20 per cents below ideal body weight) undergoing scheduled surgery under general anesthesia using fentanyl (20 patients in total)
Ideal body weight = 22 x height (m2).

Exclude 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

Related Information

• Primary Sponsor: Obara Shinju
• Source(s) of Monetary Support: Japan Society for the promotion of science