Obesity; Drug
Conditions
Keywords
Surgery, Obesity, Drug, Antibiotics, Cefuroxime
Brief summary
This study evaluates the dosage of perioperative cefuroxime for obese patients. Dosage was increased if the BMI was over 30kg/m\*m and as well over 50kg/m\*m. Drug levels were measured in blood and tissue.
Detailed description
Cefuroxime is an often used antibiotic for surgery antibiotic prophylaxis to avoid surgical wound infection. In this study the dosage of cefuroxime was adjusted to the BMI: less than 30kg/m\*m: 1,5g 31-50kg/m\*m: 3,0g more than 50kg/m\*m: 4,5g Cefuroxime was applicated 30 to 60 minutes before the begin of surgery. Drug Levels in blood and fat tissue were measured at skin cut (30-60 minutes after application of Cefuroxime), 45 minutes after skin cut (75-105 minutes after minutes after application of Cefuroxime) and at the end of surgery (up to 150 minutes after application of Cefuroxime) . The hypothesis of this study is that adequate drug levels are reached in all groups.
Interventions
DRUGCefuroxime 1,5g
Patients with BMI of \<30kg/m\*m: 1,5 g Cefuroxime
DRUGCefuroxime 3g
Patients with BMI of 30-50kg/m\*m: 3g Cefuroxime
DRUGCefuroxime 4,5g
Patients with BMI of \>50kg/m\*m: 4,5 g Cefuroxime
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
BMI: \<30kg/m\*m: 1,5g, 31-50kg/m\*m: 3,0g, \>50kg/m\*m: 4,5g
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* elective laparoscopic Intervention * BMI \< 90 kg/m\*m * age: 18-85 years
Exclusion criteria
* known history of allergy to cefuroxime or other cephalosporines * absent consent skill * elective open surgery * preoperative therapy with antibiotics * patient's denial of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of Cefuroxime | 30-60 minutes after application of cefuroxime | Drug Serum Level at skin cut |
| Tissue level of Cefuroxime | 30-60 minutes after application of cefuroxime | Drug Tissue Level at skin cut |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infections | Time until hospital discharge, estimated time period: up to two weeks | Incidence of surgical site infections |
| Hospital Retention period | Time until hospital discharge, estimated time period: 5-7 days | Length of stay in hospital |
Countries
Germany
Outcome results
None listed