Plasmatic Concentrations of Propofol and Remifentanil in Obese and Non Obese Patients. (COCOPOPONO)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; General Anesthesia
• Intervention / Treatment: Drug: Pharmacokinetic of propofol and remifentanil

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Puy De Dôme
    • Clermont-Ferrand, Puy De Dôme, France, 63000
      • Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obese patients; Severe and morbidly obese patients (35²≤BMI <55)	Drug: Pharmacokinetic of propofol and remifentanil; Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients
Active Comparator: Non Obese patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Jean-Etienne Bazin, Pr, Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): January 25, 2021
• Study Completion (Actual): May 25, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; General anesthesia; Propofol pharmacokinetic; Remifentanyl pharmacokinetic
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: COCOPOPONO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No