Clinical Trials Directory

Trials / Completed

CompletedNCT04492813

Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients.

Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University Hospital, Clermont-Ferrand · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGPharmacokinetic of propofol and remifentanilPharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients

Timeline

Start date
2018-12-20
Primary completion
2021-01-25
Completion
2021-05-25
First posted
2020-07-30
Last updated
2021-08-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04492813. Inclusion in this directory is not an endorsement.