Obese Clinical Trial
— POP-IIOfficial title:
Peri -and Postoperative Drug Therapy Schedules for Morbidly Obese Patients
Rationale: Obesity is an increasing health risk worldwide, with the USA recording prevalence
in adults of around 20%. The mean body weight of obese patients is also increasing. One of
the strategies to treat extreme obesity (Body Mass Index (BMI) > 40 kg/m2) is
weight-reducing surgery like laparoscopic gastric banding or gastric bypass. During
anaesthesia, morbidly obese patients are exposed to an increased risk at developing
postoperative wound infections, apnoea and thrombotic events and may be more difficult to
intubate. Routinely, amongst others, cefazolin, morphine, nadroparin and atracurium are
administered in standard dosages. However, it is not known to what extend the
pharmacokinetics and/or -dynamics of these drugs are affected in morbidly obese patients.
Therefore, evidence-based dosing schedules for these drugs in morbidly obese patients should
be developed.
Objective: The study is performed in order to develop population pharmacokinetic and/or
pharmacodynamic models of the routinely used drug therapies during bariatric surgery in
morbidly obese patients (BMI > 40 kg/m2): cefazolin, morphine, nadroparin and atracurium.
A covariate analysis will be performed in order to account for variability in
pharmacokinetic and/or pharmacodynamic parameters. This covariate analysis will take into
account procedure and patient bound covariates, with specific interest for body weight as a
covariate. Whenever possible, non-obese patients will be included in the covariate analysis.
The results will be used to develop individualised dosing schemes for routinely used drugs
peri-operatively in morbidly obese patients.
Study design: A randomised, prospective, observational, therapeutic and invasive study.
Study population: Morbidly obese patients with a Body Mass Index > 40 kg/m2 undergoing
laparoscopic banding or gastric bypass surgery, 18-60 years old. A total of 20 patients will
be included in the study.
Intervention (if applicable): All measurements and data collection will take place around
administration of drugs that are given according to routine clinical practice (cefazolin 2
grams for prophylaxis of infections, morphine 10 mg intravenously at the end of surgery, a
patient-controlled analgesia (PCA) pump with morphine for postoperative pain relief and
nadroparin 0,6 ml for trombo-embolic prophylaxis). For muscle relaxation, patients are
randomised to receive one of two generally accepted dosing regimen of atracurium (0.5 mg/kg
based on ideal body weight or 0.5 mg/kg based on total body weight). Peri- and
postoperatively, a maximum amount of 70 ml of blood will be collected from an indwelling
arterial line for measurement of concentrations of cefazolin, morphine, and anti-Xa
(nadroparin). One week after surgery the patient will be checked for thrombosis using
ultrasonography.
Main study parameters/endpoints:
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 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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Morbidly obese patients undergoing bariatric surgery with a BMI > 40 kg/m2, ASA I-III Exclusion Criteria: - Epilepsy, pregnancy, breastfeeding and known allergy allergies to cefazolin, morphine, nadroparin, atracurium, or benzene sulphonic acid. History of coagulation disorder or history of heparin/LMWH induced thrombocytopenia. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | St. Antonius Hospital | NIeuwegein |
Lead Sponsor | Collaborator |
---|---|
St. Antonius Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time course of the pharmacodynamic effect of atracurium | 6 months | No | |
Primary | Pharmacokinetic parameters of cefazolin in blood | 6 months | No | |
Primary | Pharmacokinetic parameters of morphine and metabolites in blood | 6 months | No | |
Primary | Time course of anti-factor Xa levels in blood following nadroparin | 6 months | No | |
Secondary | Dosing of atracurium based on total or ideal body weight | 6 months | No | |
Secondary | To compare primary endpoints (obtained in morbidly obese patients) with data of non-obese patients | 6 months | No | |
Secondary | The occurrence of postoperative wound infections | 6 months | No | |
Secondary | Postoperative pain scores, sedation scores and nausea scores | 6 months | No | |
Secondary | The occurrence of bleedings or thrombotic events | 6 months | No | |
Secondary | Required amounts of morphine (PCA) | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04105075 -
COPD in Obese Patients
|
||
Completed |
NCT04099654 -
The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
|
N/A | |
Recruiting |
NCT05857150 -
Exercise Response in Humans With Obesity
|
||
Completed |
NCT03532672 -
Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity
|
N/A | |
Completed |
NCT02618486 -
The Effects of Obesity on Non Surgical Periodontal Therapy
|
N/A | |
Completed |
NCT02086448 -
Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP)
|
N/A | |
Completed |
NCT01724515 -
PGC-1 and Mitochondrial Dysfunction in Diabetes
|
N/A | |
Completed |
NCT01724502 -
Mitochondrial Dysfunction in Diabetes
|
N/A | |
Active, not recruiting |
NCT01634204 -
Efficacy of a Web-based Weight Loss Program
|
Phase 2 | |
Completed |
NCT01479933 -
Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes
|
N/A | |
Completed |
NCT01421589 -
Growth Hormone Treatment on Phosphocreatine Recovery in Obesity
|
N/A | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT03528304 -
Native Women's Wellness: Contingency Management for Tobacco Cessation and Weight Loss
|
N/A | |
Completed |
NCT01726647 -
Metabolism Associated With Abdominal Fat Mass Distribution
|
N/A | |
Active, not recruiting |
NCT02125149 -
The Expecting Study
|
N/A | |
Completed |
NCT05737927 -
Pharmacodynamics and Pharmacokinetics of Different Glucose Bead Formulations in Obese Healthy Subjects
|
Phase 1 | |
Completed |
NCT05433506 -
Safety and Pharmacokinetics of HU6
|
Phase 1 | |
Completed |
NCT02871882 -
Ox Bile- Conjugated Bile Acids Sodium in Type II Diabetes Mellitus
|
Phase 2 | |
Completed |
NCT03298464 -
Study of NGM313 in Obese Participants
|
Phase 1 | |
Completed |
NCT05061173 -
Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
|
N/A |