Peri -and postoperative drug therapy schedules for morbidly obese patients

Peri -and postoperative drug therapy schedules for morbidly obese patients - POP-II

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33325

Enrollment

Registered

2009-07-24

Start date

2010-09-15

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

morbide obesitas extreme obesity Morbid obesity

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Primary endpoints to evaluate in morbidly obese patients are; - pharmacokinetic parameters of cefazolin in blood; - pharmacokinetic parameters of morphine and metabolites in blood; - time course of anti-factor Xa levels in blood following nadroparin; - time course of the pharmacodynamic effect of atracurium.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results