An interventional study of Pharmacokinetic of propofol and remifentanil in General Anesthesia and Obesity, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-25.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Obese patients group:
Group of non-obese patients:
Exclusion Criteria:
Severe and morbidly obese patients (35²≤BMI \<55)
Drug: Pharmacokinetic of propofol and remifentanil
Patients with normal weight or slightly overweight (19 \<BMI \<30).
Drug: Pharmacokinetic of propofol and remifentanil
Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients
Plasma concentration of Propofol
Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the exsufflation of the pneumoperitoneum
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Time frame: 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
Time frame: 5 minutes after completion of the gastric slice or ligation of the bile ducts
Plasma concentration of Remifentanil
Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia
Time frame: 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
Time frame: At the exsufflation of the pneumoperitoneum
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand