Peri -and postoperative drug therapy schedules for morbidly obese patients

Completed

Conditions: morbide obesitas
extreme obesity
Morbid obesity

Registration Number: NL-OMON33325

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Patients with a Body Mass Index > 40 kg/m2 undergoing laparoscopic banding or gastric bypass surgery, 18-60 years old, American Society of Anaesthesiologists (ASA) physical status II to III.

Exclusion Criteria

Pregnancy, breastfeeding, known allergy for cefazolin, morphine, nadroparin, atracurium, or benzene sulphonic acid. History of coagulation disorder or history of heparin/LMWH induced thrombocytopenia.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints to evaluate in morbidly obese patients are;<br /><br>- pharmacokinetic parameters of cefazolin in blood;<br /><br>- pharmacokinetic parameters of morphine and metabolites in blood;<br /><br>- time course of anti-factor Xa levels in blood following nadroparin;<br /><br>- time course of the pharmacodynamic effect of atracurium.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints to evaluate in morbidly obese patients are:<br /><br>- to compare primary endpoints (obtained in morbidly obese patients) with data<br /><br>of non-obese patients<br /><br>- the occurrence of postoperative wound infections;<br /><br>- postoperative pain scores, sedation scores and nausea scores;<br /><br>- the occurrence of bleedings or thrombotic events ;<br /><br>- required amounts of morphine (PCA);<br /><br>- to compare the time course of the pharmacodynamic effect of two different<br /><br>doses of atracurium.</p><br>