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This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.
Remifentanil and Propofol are administered intravenously as an opioid pain reliever and hypnotic pain reliever during anesthesia. Their advantages are numerous: short half-life allowing anesthesia and rapid awakening, little accumulation, allowing to adapt the level of anesthesia or sedation to each patient, few side effects.
Entropy° is an index derived from the electroencephalographic signal of patients, validated for the evaluation of the level of narcosis during general anesthesia.
ANI ° (nociception index analgesia) is an index using the ventilatory physiological variability of the sinus rhythm validated to monitor patient's analgesia during general anesthesia.
These non-invasive means of analgesia and sedation monitoring allows the clinician to ensure satisfactory levels of anesthesia by administering products at minimum effective doses.
The authors propose to determine whether, for a comparable target effect (analgesia and monitored sedation), plasmatic concentrations and administration rates of propofol and remifentanil necessary during general anesthesia for a comparable surgical stimulus are the same in populations of obese and non obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients | Experimental | Severe and morbidly obese patients (35²≤BMI <55) |
|
| Non Obese patients | Active Comparator | Patients with normal weight or slightly overweight (19 \ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic of propofol and remifentanil | Drug | Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Propofol | Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia | 5 minutes after the insufflation of the pneumoperitoneum |
| Plasma concentration of Propofol | Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia | 5 minutes after completion of the gastric slice or ligation of the bile ducts |
| Plasma concentration of Propofol | Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia | At time of removing surgical specimen from the abdomen |
| Plasma concentration of Propofol | Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia | At the exsufflation of the pneumoperitoneum |
| Plasma concentration of Remifentanil | Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia | 5 minutes after the insufflation of the pneumoperitoneum |
| Plasma concentration of Remifentanil | Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia | 5 minutes after completion of the gastric slice or ligation of the bile ducts |
| Plasma concentration of Remifentanil |
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Inclusion Criteria:
Obese patients group:
Group of non-obese patients:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Etienne Bazin, Pr | Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand | Clermont-Ferrand | Puy De Dôme | 63000 | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Each obese patient is matched with a non-obese patient by considering a pairing according to age (more or less 5 years), gender and renal function (more or less 10ml / min / 1.73m² creatinine clearance).
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Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
| At time of removing surgical specimen from the abdomen |
| Plasma concentration of Remifentanil | Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia | At the exsufflation of the pneumoperitoneum |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |