Study on pharmacokinetics of cefmetazole for over-weight or under-weight patients

JRCT ID: jRCTs061200055

Registered date:16/02/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lower gastrointestinal disease with surgical indication (regardless of benign or malignant)
• Date of first enrollment: 27/04/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

<drug administration >
Cefmetazole is administered intravenously as prophylactic antibiotics. The dose based on recommendation of the guideline. For patients weighing over 80 kg, use a single dose of 2 grams of cefmetazole. For patients weighing less than 80 kg, use a single dose of 1 gram of cefmetazole. Cefmetazole is administered just before the surgery and during surgery.
<sample collection>
Blood (approx. 2 ml), peritoneal fluid (approx. 2 ml), subcutaneous adipose tissue (approx. 4 mm square) and peritoneum (approx. 4 mm square) are collected 30 minutes after the start of the first drug administration and every hour thereafter till the end of the surgery.
<drug concentration measurement>
After collecting the samples, measure the drug concentration. Analyzing the results, drug concentration in plasma, peritoneal fluid, peritoneum, subcutaneous adipose tissue and pharmacokinetic parameters are compared and examined.

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters (Cmax, AUC, T1/2, Tmax) of drug in plasma, peritoneal fluid and abdominal tissues (peritoneum and subcutaneous adipose tissue)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Patients scheduled for elective lower gastrointestinal surgery (regardless of open surgery or laparoscopic surgery)
2 Patients weight over 80 kg and BMI 25 kg/m2 or weight less than 40kg and BMI 18.5 kg/m2 or patients excluding weight and BMI already shown.
3 Patients over 20 years old, regardless of gender
4 Patients who can give written informed consent to participate in this study

Exclude criteria

1 Patients with a history of allergies to Cefmetazole
2 Patients with a history of allergies to cephems
3 Patients who take drugs require caution in combination use
4 Patients who are pregnant or nursing
5 Patients with diseases in the brain and spinal cord
6 Patients with renal dysfunction who have creatinine clearance less than 50 ml / min estimated by Cockcroft-Gault equation (Use ideal body weight for patients weighing over 80kg)
7 Patients judged inappropriate for this study by the researcher

Related Information

• Primary Sponsor: Ohge Hiroki