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

Not Applicable

Completed

• Conditions: Obesity; General Anesthesia
• Interventions: Drug: Pharmacokinetic of propofol and remifentanil

• Registration Number: NCT04492813
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Primary Completion: 2021-01-25
• Study Completion: 2021-05-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Obese patients group:

• Age ≥ 18 years old
• Severe and morbidly obese patients (35kg / m2≤IMC <55kg / m2).
• Patients undergoing general anesthesia for laparoscopic susmesocolic surgery (bariatric surgery or cholecystectomy).
• Patients who have given their consent in the manner described by the public health law of August 9, 2004.
• Patients benefiting from a Social Security scheme.

Group of non-obese patients:

• Age ≥ 18 years old
• Patients with normal weight or slightly overweight (19 <BMI <30).
• Patients receiving general anesthesia for laparoscopic susmesocolic surgery (cholecystectomy).
• Patients who have given their consent in the manner described by the public health law of August 9, 2004.
• Patients benefiting from a Social Security scheme.

Exclusion Criteria

• Patient refusal
• Age <18 years old
• Protected adults and vulnerable persons
• Pace maker
• General anesthesia in the 24 hours preceding this surgery
• Proven or suspected dysautonomia
• Premedication by gabapentin Neurontin °
• Locoregional peri-medullary analgesia technique used concomitantly during the pre- and intraoperative period.
• Unbalanced dysrhythmic heart disease (AC / FA; extrasystoles; non-sinus rhythm)
• Pregnant or breastfeeding woman
• Intubation impossible planned
• Hypersensitivity to the products used
• Allergy to peanut or soy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese patients	Pharmacokinetic of propofol and remifentanil	Severe and morbidly obese patients (35²≤BMI \<55)
Non Obese patients	Pharmacokinetic of propofol and remifentanil	Patients with normal weight or slightly overweight (19 \<BMI \<30).

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Propofol	At the exsufflation of the pneumoperitoneum	Plasma concentration of Propofol at different times during the maintenance phase of general anesthesia
Plasma concentration of Remifentanil	At the exsufflation of the pneumoperitoneum	Plasma concentration of Remifentanil at different times during the maintenance phase of general anesthesia

Trial Locations

Locations (1)

Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Puy De Dôme, France